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CompletedNCT02119325Updated May 15, 2015Results posted

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

An interventional study of 25% fibre and 0% fibre in Impaired Fasting Glucose, sponsored by GlaxoSmithKline. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by GlaxoSmithKline · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.

02

Conditions studied

  • Impaired Fasting Glucose

Keywords

  • fibre
  • overweight
  • impaired fasting glucose
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy overweight male and female participants
  • Age 18-75 years
  • BMI ≥25\<35 Kg/m2

Exclusion criteria

Exclusion Criteria:

  • Pregnancy/breast-feeding
  • Allergy/Intolerance
  • Anaemic participants: Hb \<10g/dL
  • Diabetic participants: fasting blood glucose >125 mg/dL
  • Serum Aspartate Transaminase, Alkaline Phosphatase and Serum albumin level 3 times the upper limit of normal range
  • Participants on other medications (lipid lowering drugs, oral hypoglycemics)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Test

    Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water

    Dietary Supplement: 25% fibre

  • Placebo comparator
    Placebo

    No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water

    Dietary Supplement: 0% fibre

Interventions

  • Dietary supplement25% fibre

    Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)

  • Dietary supplement0% fibre

    Placebo is an energy matched powdered beverage

06

What researchers measure

Primary outcomes

  1. Cmax for Glucose in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  2. Cmax for Triglyceride in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Secondary outcomes

  1. Cmax for Glucose in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  2. AUC for Glucose in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  3. Tmax for Glucose in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  4. Cmax for Triglyceride in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  5. AUC for Triglycerides in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  6. Tmax for Triglycerides in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  7. Cmax for RLP Cholesterol in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  8. AUC for RLP Cholesterol in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  9. Tmax for RLP Cholesterol in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  10. Cmax for RLP Cholesterol in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  11. AUC for RLP Cholesterol in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  12. Tmax for RLP Cholesterol in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  13. Cmax for Insulin in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  14. AUC for Insulin in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  15. Tmax for Insulin in IFG Status Participants

    To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  16. Cmax for Insulin in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  17. AUC for Insulin in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

  18. Tmax for Insulin in Overweight Healthy Participants

    To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults

    Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

07

Results

Posted May 15, 2015

Participant flow

Participants were mainly recruited from the study site database.

Period 1
Participant flow — Period 1
MilestoneSequence 1Sequence 2
Started4848
Completed4848
Not completed00
Washout Period 1
Participant flow — Washout Period 1
MilestoneSequence 1Sequence 2
Started4848
Completed4847
Not completed01
Withdrew: Adverse event01
Period 2
Participant flow — Period 2
MilestoneSequence 1Sequence 2
Started4847
Completed4847
Not completed00

Outcome measures

PrimaryCmax for Glucose in IFG Status Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg/dL
Cmax for Glucose in IFG Status Participants
mg/dLTestPlacebo
Cmax for Glucose in IFG Status Participants42.76 ± 24.22947.40 ± 23.233
Statistical analysis
  • Test vs Placebo · ANOVA · p = 0.0487 (Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.) · Difference in adjusted mean: -4.64 · 95% CI -9.26 to -0.03Difference is test minus placebo such that a positive difference means the test has higher Cmax
PrimaryCmax for Triglyceride in IFG Status Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg/dL
Cmax for Triglyceride in IFG Status Participants
mg/dLTestPlacebo
Cmax for Triglyceride in IFG Status Participants121.07 ± 46.484127.85 ± 72.565
Statistical analysis
  • Test vs Placebo · ANOVA · p = 0.6116 (Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.) · Difference in adjusted mean: -6.79 · 95% CI -34.02 to 20.44Difference is test minus placebo such that a positive difference means the test has higher Cmax
SecondaryCmax for Glucose in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg/dL
Cmax for Glucose in Overweight Healthy Participants
mg/dLTestPlacebo
Cmax for Glucose in Overweight Healthy Participants38.98 ± 17.68743.64 ± 19.220
SecondaryAUC for Glucose in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg*min/dL
AUC for Glucose in Overweight Healthy Participants
mg*min/dLTestPlacebo
AUC for Glucose in Overweight Healthy Participants27163.93 ± 2804.54927329.59 ± 3040.290
SecondaryTmax for Glucose in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for Glucose in Overweight Healthy Participants
minutesTestPlacebo
Tmax for Glucose in Overweight Healthy Participants25.74 ± 15.71025.78 ± 11.972
SecondaryCmax for Triglyceride in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg/dL
Cmax for Triglyceride in Overweight Healthy Participants
mg/dLTestPlacebo
Cmax for Triglyceride in Overweight Healthy Participants126.20 ± 51.959119.84 ± 56.151
SecondaryAUC for Triglycerides in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mg*min/dL
AUC for Triglycerides in Overweight Healthy Participants
mg*min/dLTestPlacebo
AUC for Triglycerides in Overweight Healthy Participants59829.76 ± 27022.97260488.97 ± 29642.057
SecondaryTmax for Triglycerides in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for Triglycerides in Overweight Healthy Participants
minutesTestPlacebo
Tmax for Triglycerides in Overweight Healthy Participants220.32 ± 37.115218.75 ± 30.444
SecondaryCmax for RLP Cholesterol in IFG Status Participants

To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mmole/L
Cmax for RLP Cholesterol in IFG Status Participants
mmole/LTestPlacebo
Cmax for RLP Cholesterol in IFG Status Participants0.82 ± 0.7801.30 ± 1.265
SecondaryAUC for RLP Cholesterol in IFG Status Participants

To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mmole*min/L
AUC for RLP Cholesterol in IFG Status Participants
mmole*min/LTestPlacebo
AUC for RLP Cholesterol in IFG Status Participants1765.27 ± 237.9511759.01 ± 230.544
SecondaryTmax for RLP Cholesterol in IFG Status Participants

To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for RLP Cholesterol in IFG Status Participants
minutesTestPlacebo
Tmax for RLP Cholesterol in IFG Status Participants124.23 ± 84.068125.00 ± 77.006
SecondaryCmax for RLP Cholesterol in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mmole/L
Cmax for RLP Cholesterol in Overweight Healthy Participants
mmole/LTestPlacebo
Cmax for RLP Cholesterol in Overweight Healthy Participants0.97 ± 1.0091.33 ± 1.783
SecondaryAUC for RLP Cholesterol in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · mmole*min/L
AUC for RLP Cholesterol in Overweight Healthy Participants
mmole*min/LTestPlacebo
AUC for RLP Cholesterol in Overweight Healthy Participants1856.49 ± 1049.3721845.29 ± 904.018
SecondaryTmax for RLP Cholesterol in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for RLP Cholesterol in Overweight Healthy Participants
minutesTestPlacebo
Tmax for RLP Cholesterol in Overweight Healthy Participants116.84 ± 77.088130.26 ± 76.507
SecondaryCmax for Insulin in IFG Status Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · µIU/mL
Cmax for Insulin in IFG Status Participants
µIU/mLTestPlacebo
Cmax for Insulin in IFG Status Participants190.90 ± 75.471214.90 ± 84.080
SecondaryAUC for Insulin in IFG Status Participants

To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · µIU*min/mL
AUC for Insulin in IFG Status Participants
µIU*min/mLTestPlacebo
AUC for Insulin in IFG Status Participants24920.06 ± 10299.88827066.11 ± 10666.718
SecondaryTmax for Insulin in IFG Status Participants

To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for Insulin in IFG Status Participants
minutesTestPlacebo
Tmax for Insulin in IFG Status Participants38.46 ± 23.94939.23 ± 19.115
SecondaryCmax for Insulin in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · µIU/mL
Cmax for Insulin in Overweight Healthy Participants
µIU/mLTestPlacebo
Cmax for Insulin in Overweight Healthy Participants188.84 ± 87.184213.42 ± 100.641
SecondaryAUC for Insulin in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · µIU*min/mL
AUC for Insulin in Overweight Healthy Participants
µIU*min/mLTestPlacebo
AUC for Insulin in Overweight Healthy Participants21963.63 ± 10310.80025089.69 ± 13421.113
SecondaryTmax for Insulin in Overweight Healthy Participants

To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults

Time frame:
Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Reported as:
Mean · minutes
Tmax for Insulin in Overweight Healthy Participants
minutesTestPlacebo
Tmax for Insulin in Overweight Healthy Participants35.58 ± 24.17636.41 ± 21.048

Adverse events

Collected over Adverse events were recorded from the start of the investigational product, and until one day following last administration of the investigational product.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test—0/96 (0%)0/96 (0%)
Placebo—0/96 (0%)1/96 (1%)
Most frequent other events
Most frequent other events
EventTestPlacebo
DiarrhoeaGastrointestinal disorders0/961/96

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Overall Participants
Mean33.9 ± 7.42
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female0
Male96
Impaired fasting glucose (IFG) status
Impaired fasting glucose (IFG) status(participants)Overall Participants
IFG26
No IFG70
08

Study locations

1 site
  • Lambda Therapeutic Research Ltd
    Ahmedabad, Gujarat 380 061, India
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02119325
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Sep 2013
Primary completion
Oct 2013
Results posted
May 15, 2015
Last update
May 15, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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