An interventional study of Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in Type2 Diabetes, sponsored by Mondelēz International, Inc.. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention
Among 414 studies in Diabetes Mellitus, Type 2 with a site in France — 36 open to participants now, 42 under way, 9 of them phase 3. Diabetes Mellitus, Type 2 · France.
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, this one is the 263rd largest by enrollment of the 336 interventional ones, is one of 15 that started in 2019, is one of 112 with no phase, and was the 309th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 53 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →36 of the 414 studies in Diabetes Mellitus, Type 2 with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →414 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 15 started in 2019.
Median enrollment 312 across the 336 interventional studies, 276 across the 78 observational. Of the 335 that completed or were terminated, 132 (39%) have results posted.
234 of 414 have an industry lead sponsor. The 10 most frequent:
Mondelēz International, Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Mondelēz International, Inc. has 4 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus, Type 2 with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05882071Boehringer IngelheimNon-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France | 2026-11-30 |
| NCT06579404University of CambridgeClosed-loop in Adults With Type 2 Diabetes | 2027-03 |
| NCT06567990Hospices Civils de LyonType 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes | 2027-05-25 |
| NCT06614101University Hospital, ToulouseStudy Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air | 2027-05-31 |
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, from their registry updates:
This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.
This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.
80 patients with type 2 diabetes will be recruited.
Subjects will have 11 visits:
V0 = selection visit: check whether the patients fulfill inclusion and exclusion criteria for the study.
Visit V1 = CGMS insertion on usual lifestyle without any changes in his/her diet. This is the Run-in period.
Visit V2 (6 days +/- 1 day) = CGMS removal and randomization according to sex, HbA1c and MAGE.
Visit V3 = first metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS insertion with detailed dietetic instructions according to their allocated group (adapted food provisions).
Visit V4 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.
Visit V5 = Adapted food provisions.
Visit V6 = medical check-up, dietary interview, CGMS insertion and baseline blood measurements. Adapted food provisions.
Visit V7 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.
Visit V8 = Adapted food provisions.
Visit V9 = CGMS insertion. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.
Visit V10 (6 days +/- 1 day) = second metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS removal. Feedback questionnaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Balanced diet high in Slowly Digestible Starch
Other: Balanced diet high in Slowly Digestible Starch
Balanced diet low in Slowly Digestible Starch
Other: Balanced diet low in Slowly Digestible Starch
The carbohydrates present in high Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.
Also known as: Diet A, H-SDS
The carbohydrates present in low-Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.
Also known as: Diet B, L-SDS
MAGE comparison following 3 months of intake of a diet either high or low in SDS
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Time frame: Minimum 3 days to a maximum of 6 days of CGMS record
Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Glycemia iAUC
Time frame: 5 hours post standard challenge test during visit 3
Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Insulin iAUC
Time frame: 5 hours post standard challenge test during visit 3
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
GLP1 iAUC
Time frame: 5 hours post standard challenge test during visit 3
Inflammatory status comparison during the first metabolic day : CRPus concentration
CRPus
Time frame: At a basal state during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : TNFa iAUC
TNFa iAUC
Time frame: 5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL6 iAUC
IL6 iAUC
Time frame: 5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL1Ra iAUC
IL1Ra iAUC
Time frame: 5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC
IL18 iAUC
Time frame: 5 hours post standard challenge test during visit 3
Glycemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study
Glycemia concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study
Insulin concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration
CRPus concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration
TNFa concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration
IL6 concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration
IL1Ra concentration
Time frame: At a basal state during visit V3, V6 and V10
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration
IL18 concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration
Malonaldehyde : MDA concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration
Urinary isoprostanes concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : MCP1 concentration
MCP1 concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration
sICAM concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration
sVCAM concentration
Time frame: At a basal state during visit 3, visit 6 and visit 10
Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day
Glycemia iAUC
Time frame: 5 hours post standard challenge test during visit 10
Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day
Insulin iAUC
Time frame: 5 hours post standard challenge test during visit 10
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day
GLP1 iAUC
Time frame: 5 hours post standard challenge test during visit 10
Inflammatory impacts comparison following 3 months of intake of a diet either high or low in SDS : CRPus concentration
CRPus concentration
Time frame: At a basal state during visit 10
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC
TNFa iAUC
Time frame: 5 hours post standard challenge test during visit 10
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC
IL6 iAUC
Time frame: 5 hours post standard challenge test during visit 10
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC
IL1Ra iAUC
Time frame: 5 hours post standard challenge test during visit 10
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC
IL18 iAUC
Time frame: 5 hours post standard challenge test during visit 10
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : MCP1 concentration
MCP1 concentration
Time frame: After 3 months consumption of the diet
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sICAM concentration
sICAM concentration
Time frame: After 3 months consumption of the diet
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sVCAM concentration
sVCAM concentration
Time frame: After 3 months consumption of the diet
Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration
Malonaldehyde : MDA concentration
Time frame: After 3 months consumption of the diet
Oxydative stress characterisation following the intake of a diet either high or low in SDS : Urinary isoprostanes concentration
Urinary isoprostanes concentration
Time frame: After 3 months consumption of the diet
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MAGE
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : TIR
Time In Range (TIR) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR
Time In Range (TIR) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV
Coefficient of Variation (CV) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CV
Coefficient of Variation (CV) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD
Standard Deviation (SD) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : SD
Standard Deviation (SD) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MIME
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD
Mean Of Daily Differences (MODD) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MODD
Mean Of Daily Differences (MODD) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA
Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CONGA
Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR
Average Daily Risk Range (ADRR) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : ADRR
Average Daily Risk Range (ADRR) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI
Low Blood Glucose Index (LGBI) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : LGBI
Low Blood Glucose Index (LGBI) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI
High Blood Glucose Index (HGBI) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : HGBI
High Blood Glucose Index (HGBI) from CGMS glycaemia
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Mean daylong incremental Area Under the Curve (iAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study
The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.
Time frame: from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)
Mean daylong total Area Under the Curve (tAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study
The tAUC will be calculated using the trapezoid rule.
Time frame: from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)
Compare diabetes follow-up markers during the first metabolic day : HbA1c
Hba1c concentration
Time frame: At the basal state during visit 3
Compare diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : HbA1c concentration
Hba1c
Time frame: At a basal state, during visit 3, visit 6 and visit 10
Compare diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : HbA1c concentration
Hba1c
Time frame: After 3 months consumption of the diet, at the basal state
Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration
Fructosamine
Time frame: At the basal state during visit 3
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : fructosamine concentration
Fructosamine
Time frame: At a basal state, during visit 3, visit 6 and visit 10
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Fructosamine concentration
Fructosamine
Time frame: After 3 months consumption of the diet, at the basal state
Compare Diabetes follow-up markers during the first metabolic day : Glycated Albumin concentration
Glycated albumin
Time frame: At the basal state during visit 3
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : glycated albumin concentration
Glycated albumin
Time frame: At a basal state, during visit 3, visit 6 and visit 10
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Glycated Albumin concentration
Glycated albumin
Time frame: After 3 months consumption of the diet, at the basal state
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : RHI
Reactive Hyperemia (RHI)
Time frame: At a basal state during visit 4, visit 7 and visit 9
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : AI
Augmentation Index (AI)
Time frame: At a basal state during visit 4, visit 7 and visit 9
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : HRV
Heart Rate Variability (HRV)
Time frame: At a basal state during visit 4, visit 7 and visit 9
Anthropometry parameters characterisation during the first metabolic day : height
Height
Time frame: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : body weight
body weight
Time frame: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : waist circumference
waist circumference
Time frame: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : hip circumference
hip circumference
Time frame: At baseline during visit 3
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : height
Height
Time frame: At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : body weight
body weight
Time frame: At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : waist circumference
waist circumference
Time frame: At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : hip circumference
hip circumference
Time frame: At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : height
Height
Time frame: At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body weight
body weight
Time frame: At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : waist circumference
waist circumference
Time frame: At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : hip circumference
hip circumference
Time frame: At baseline during visit 10
Body composition parameters characterisation during the first metabolic day: total body water
Total body water measured by bioimpedancemetry
Time frame: At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: body fat
Body fat measured by bioimpedancemetry
Time frame: At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: lean mass.
Lean mass measured by bioimpedancemetry
Time frame: At baseline during visit 3
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : total body water
Total body water measured by bioimpedancemetry
Time frame: At baseline during visit 10
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body fat
Body fat measured by bioimpedancemetry
Time frame: At baseline during visit 10
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : lean mass
Lean mass measured by bioimpedancemetry
Time frame: At baseline during visit 10
Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate
Resting Metabolism Rate (RMR)
Time frame: At baseline during visit 3
Resting energy metabolism profile following the 3 months consumption of a diet either high or low in SDS : Resting Metabolism Rate
Resting Metabolism Rate (RMR)
Time frame: At baseline during visit 10
Diabetic glycemic variability characterisation following the 3 months consumption of a diet either high or low in SDS
Percent of subjects reaching the target for HbA1C, TIR and CV
Time frame: after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ
International Physical Activity Questionnaire (IPAQ)
Time frame: After each CGMS record periods, ie : at visit 4, visit 7 and visit 10
Characterisation of acceptability to H-SDS diet in free living conditions
Feedback questionnaire
Time frame: After 3 months consumption of the diet, at visit 10
Characterisation of the percent of compliance to H-SDS diet in free living conditions
Table of compliance in the volunteer's notebook. Subjects will have to fulfill it after each meal during the study period
Time frame: After 3 months consumption of the diet
Plan to share: No
Ran from Jun 2019 to primary completion in Nov 2024, 64 months.
Of 177 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's 64 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Mondelēz International, Inc. →