ClinicalTrials.gg
Active, not recruitingNCT06714552SURE-BloGUpdated Jun 18, 2026

Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults

An interventional study of Galacto-Oligosaccharide and Glucose in Postprandial Hyperglycemia and Hyperinsulinemia, sponsored by University of Aberdeen. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by University of Aberdeen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Diabetes and cardiovascular disease account for millions of deaths per year. One of the risk factors for both conditions is high blood sugar, particularly after eating (postprandial hyperglycaemia). Lowering blood sugar levels after a meal is expected to have a positive effect on preventing metabolic and cardiovascular diseases and improving the metabolic control of those who already suffer from these conditions.

The aim of this study is to investigate the effect of Oligomate® (beta-galacto-oligosaccharide) on postprandial glycaemia when used as a partial replacement of glycaemic carbohydrates in a beverage in otherwise healthy volunteers. Volunteers will be given water with either Oligomate® or glucose (control) added. Blood samples will be collected at eight time points (two before drinking the beverage and six after) to measure glucose and insulin levels.

Read the detailed description

A single-centre, single-blind, randomised, controlled, cross-over, acute feeding trial will be conducted. The recruitment and study visits will be carried out at the Human Intervention Studies Unit (HISU) of the Rowett Institute.

A recruitment visit will be scheduled to screen for eligibility. During the visit, informed consent will be obtained before volunteers complete a health questionnaire, have their height and weight measured, and their veins checked to assess suitability for blood sample collection. A finger prick blood sample will then be taken to measure HbA1c levels. If a volunteer is eligible, the first study visit will be scheduled and they will be asked to fast for 12 hours the night before. A frozen high carbohydrate vegetarian ready-meal will be provided, which they will consume at home the evening before the study visit and before the fasting period.

During the study visits, the postprandial glycaemic response will be measured immediately after consumption of the supplement or control on two occasions separated by a wash-out period of 7-14 days. Briefly, subjects will arrive in the morning after having consumed the high carbohydrate meal the night before, followed by a 12 hr overnight fast. After recording body weight, a cannula will be inserted into an antecubital vein of one arm by a trained cannulist to allow repeated blood sampling during the assessment (approx. 6 ml collected per sample time to a total of 48 ml per visit). After obtaining two initial fasting blood samples (at -10min and -5min), subjects will consume the test beverage within 5 min. Further blood samples will be obtained at 15, 30, 45, 60, 90 and 120 min after ingestion to complete the postprandial glycaemic response assessment.

At the end of the first visit volunteers will receive the second ready-meal, identical to the first, which they will be asked to consume the evening before the second study visit, before the fasting period commences. During the second study visit, participants will consume the same beverage with the alternate supplement and complete the opposite arm of the postprandial glycaemic response assessment.

02

Conditions studied

  • Postprandial Hyperglycemia
  • Hyperinsulinemia

Keywords

  • galacto-oligosaccharides
  • postprandial glycaemia
  • GOS
03

In context

Hyperglycemia

800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 620 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 176 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy Men or Women
  • (BMI) 18.5-29.9 kg/m\^2
  • Between 18 and 65 years of age
  • Compliant (i.e., understands and is willing, able, and likely to comply with the experimental procedure and safety guidelines)
  • Able to provide
  • Premenopausal women must have a regular cycle or be on hormonal .

Exclusion criteria

Exclusion Criteria:

  • Diabetes mellitus (all types including gestational diabetes)
  • result over the study limit [healthy range of between 4% and 5.9%]
  • Endocrine disease (e.g., Cushing's syndrome)
  • Any food allergy or intolerance, or following Vegan diet
  • Medications that increase blood glucose (e.g., , protease inhibitors, antipsychotics, antihypertensives, statins, diuretics, nicotinic acid, etc.)
  • Medications that lower glycemia (e.g., anti-hyperglycaemics, insulin, beta- blockers, etc.)
  • Medication affecting glucose regulation, appetite, and/or digestion/absorption of nutrients, antibiotics
  • Major medical or surgical event requiring hospitalization in the previous 3 months
  • Pregnant or lactating
  • Participation in another clinical/supplementation trial or actively trying to reduce body weight
  • Unable to comply with experimental procedures and safety guidelines
  • Unable to give consent
  • Smokers
  • Travel during the study period
Terms in these criteria, in plain language(5)

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.

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Beta-galacto-oligosaccharide

    Dietary Supplement: Galacto-Oligosaccharide

  • Other
    Glucose

    Control

    Other: Glucose

Interventions

  • Dietary supplementGalacto-Oligosaccharide

    24.0 g Oligomate® in 100 mL water

  • OtherGlucose

    17.8 g glucose in 100 mL water

06

What researchers measure

Primary outcomes

  1. Difference in plasma glucose incremental area under the curve (iAUC) between study arms

    Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. iAUC will be calculated using the trapezoidal rule with the baseline value of fasting plasma glucose subtracted.

    Time frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

Secondary outcomes

  1. Difference in plasma glucose total area under the curve (tAUC) between study arms

    Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. tAUC will be calculated using the trapezoidal rule with zero as the baseline.

    Time frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

  2. Difference in peak plasma glucose concentration between study arms

    Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. The peak plasma glucose concentrations for each arm will be compared.

    Time frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

  3. Measured maximal incremental glucose value (iCMax) between study arms

    Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. iCMax will be calculated using fasting plasma glucose levels as baseline.

    Time frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

  4. Difference in plasma insulin iAUC between study arms

    Plasma insulin levels will be determined using ELISA from blood samples obtained, at several time points. iAUC will be calculated using the trapezoidal rule with baseline value of fasting plasma insulin subtracted.

    Time frame: baseline, 30, 60, 120 min after beverage consumption

  5. Difference in plasma insulin tAUC between study arms

    Plasma insulin levels will be determined using ELISA from blood samples obtained at several time points. tAUC will be calculated using the trapezoidal rule with zero as the baseline.

    Time frame: baseline, 30, 60, 120 min after beverage consumption

  6. Difference in peak plasma insulin concentration between study arms

    Plasma insulin will be determined using ELISA from blood samples obtained at several time points. Peak plasma insulin levels for each arm will be compared.

    Time frame: baseline, 30, 60, 120 min after beverage consumption

07

Study locations

1 site
  • University of Aberdeen, Rowett Institute
    Aberdeen, AB25 2ZD, United Kingdom
08

References and documents

Publications

  • Venn BJ, Green TJ. Glycemic index and glycemic load: measurement issues and their effect on diet-disease relationships. Eur J Clin Nutr. 2007 Dec;61 Suppl 1:S122-31. doi: 10.1038/sj.ejcn.1602942. PubMed 17992183 ↗
  • Wright E Jr, Scism-Bacon JL, Glass LC. Oxidative stress in type 2 diabetes: the role of fasting and postprandial glycaemia. Int J Clin Pract. 2006 Mar;60(3):308-14. doi: 10.1111/j.1368-5031.2006.00825.x. PubMed 16494646 ↗
  • Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto L, Brouns F, Diamant M, Dye L, Hulshof T, Holst JJ, Lamport DJ, Laville M, Lawton CL, Meheust A, Nilson A, Normand S, Rivellese AA, Theis S, Torekov SS, Vinoy S. Impact of postprandial glycaemia on health and prevention of disease. Obes Rev. 2012 Oct;13(10):923-84. doi: 10.1111/j.1467-789X.2012.01011.x. Epub 2012 Jul 11. PubMed 22780564 ↗
  • Neri S, Calvagno S, Mauceri B, Misseri M, Tsami A, Vecchio C, Mastrosimone G, Di Pino A, Maiorca D, Judica A, Romano G, Rizzotto A, Signorelli SS. Effects of antioxidants on postprandial oxidative stress and endothelial dysfunction in subjects with impaired glucose tolerance and type 2 diabetes. Eur J Nutr. 2010 Oct;49(7):409-16. doi: 10.1007/s00394-010-0099-6. Epub 2010 Mar 7. PubMed 20213326 ↗
  • Bonora E. Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl. 2002 Jul;(129):5-11. PubMed 12166607 ↗
  • Levitan EB, Song Y, Ford ES, Liu S. Is nondiabetic hyperglycemia a risk factor for cardiovascular disease? A meta-analysis of prospective studies. Arch Intern Med. 2004 Oct 25;164(19):2147-55. doi: 10.1001/archinte.164.19.2147. PubMed 15505129 ↗
  • Lin PJ, Borer KT. Third Exposure to a Reduced Carbohydrate Meal Lowers Evening Postprandial Insulin and GIP Responses and HOMA-IR Estimate of Insulin Resistance. PLoS One. 2016 Oct 31;11(10):e0165378. doi: 10.1371/journal.pone.0165378. eCollection 2016. PubMed 27798656 ↗
  • Hinnen DA. Therapeutic Options for the Management of Postprandial Glucose in Patients With Type 2 Diabetes on Basal Insulin. Clin Diabetes. 2015 Oct;33(4):175-80. doi: 10.2337/diaclin.33.4.175. PubMed 26487791 ↗
  • Kamruzzaman M, Horowitz M, Jones KL, Marathe CS. Gut-Based Strategies to Reduce Postprandial Glycaemia in Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Apr 9;12:661877. doi: 10.3389/fendo.2021.661877. eCollection 2021. PubMed 33897622 ↗
  • Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18. PubMed 33208922 ↗
  • Jenkins DJ, Goff DV, Leeds AR, Alberti KG, Wolever TM, Gassull MA, Hockaday TD. Unabsorbable carbohydrates and diabetes: Decreased post-prandial hyperglycaemia. Lancet. 1976 Jul 24;2(7978):172-4. doi: 10.1016/s0140-6736(76)92346-1. PubMed 73796 ↗
  • Bonsu NKA, Johnson S. Effects of inulin fibre supplementation on serum glucose and lipid concentration in patients with type 2 diabetes. International Journal of Diabetes and Metabolism. 2012 12;20(3):80-6. doi: 10.1159/000497730.
  • Dehghan P, Pourghassem Gargari B, Asgharijafarabadi M. Effects of high performance inulin supplementation on glycemic status and lipid profile in women with type 2 diabetes: a randomized, placebo-controlled clinical trial. Health Promot Perspect. 2013 Jun 30;3(1):55-63. doi: 10.5681/hpp.2013.007. eCollection 2013. PubMed 24688953 ↗
  • Luo J, Van Yperselle M, Rizkalla SW, Rossi F, Bornet FR, Slama G. Chronic consumption of short-chain fructooligosaccharides does not affect basal hepatic glucose production or insulin resistance in type 2 diabetics. J Nutr. 2000 Jun;130(6):1572-7. doi: 10.1093/jn/130.6.1572. PubMed 10827212 ↗
  • Gargari BP, Namazi N, Khalili M, Sarmadi B, Jafarabadi MA, Dehghan P. Is there any place for resistant starch, as alimentary prebiotic, for patients with type 2 diabetes? Complement Ther Med. 2015 Dec;23(6):810-5. doi: 10.1016/j.ctim.2015.09.005. Epub 2015 Sep 16. PubMed 26645521 ↗
  • Liu F, Li P, Chen M, Luo Y, Prabhakar M, Zheng H, He Y, Qi Q, Long H, Zhang Y, Sheng H, Zhou H. Fructooligosaccharide (FOS) and Galactooligosaccharide (GOS) Increase Bifidobacterium but Reduce Butyrate Producing Bacteria with Adverse Glycemic Metabolism in healthy young population. Sci Rep. 2017 Sep 18;7(1):11789. doi: 10.1038/s41598-017-10722-2. PubMed 28924143 ↗
  • Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25. PubMed 31983281 ↗
  • Lightowler H, Thondre S, Holz A, Theis S. Replacement of glycaemic carbohydrates by inulin-type fructans from chicory (oligofructose, inulin) reduces the postprandial blood glucose and insulin response to foods: report of two double-blind, randomized, controlled trials. Eur J Nutr. 2018 Apr;57(3):1259-1268. doi: 10.1007/s00394-017-1409-z. Epub 2017 Mar 3. PubMed 28255654 ↗

Individual participant data

Plan to share: No — The study is designed to look at average responses to the supplement. There is no need to share individual participant data.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Apr 2026, 14 months.

Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 14 months is close to that.

Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2024
First posted
Dec 3, 2024
StartActual
Jan 17, 2025
Primary completionActual
Apr 13, 2026
CompletionEst.
Jul 31, 2026
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06714552
Collaborators
Yakult Honsha Co., LTD
Responsible party
Sponsor
First posted
Dec 3, 2024
Start date
Jan 17, 2025
Primary completion
Apr 13, 2026
Completion
Jul 31, 2026 (estimated)
Last update
Jun 18, 2026

Study contacts

Karen Scott, PhD
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Discussion

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Studies of the drug tested here: 4'-Galactooligosaccharide

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