Impaired Fasting GlucoseNCT02119325

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

A study testing 25% fibre and 0% fibre in people with Impaired Fasting Glucose, run by GlaxoSmithKline at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Impaired Fasting Glucose
What is being tested?: 25% fibre and 0% fibre
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteIndia
Study dates: Sep 2013to Oct 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

India1 site

Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, 380 061

Other trials in India

About this study

Conditions: Impaired Fasting Glucose
Being tested: 25% fibre, 0% fibre
Keywords: fibre, overweight, impaired fasting glucose
Medical subject headings: Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

25% fibreDietary supplement
Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)
0% fibreDietary supplement
Placebo is an energy matched powdered beverage

Study groups in NCT02119325
Study group	Role	What they receive
Test	Experimental	Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water Receives: Dietary Supplement: 25% fibre
Placebo	Placebo comparator	No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water Receives: Dietary Supplement: 0% fibre

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Oct 2013

First posted21 Apr 2014 (estimated)
Study startSep 2013
Primary completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02119325
Sponsor's protocol ID: 202180
Other IDs: RH01899
Status last verified: Apr 2015
First submitted: 17 Apr 2014
Last updated: 15 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaired Fasting Glucose trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population
ClinicalTrials.gov ID: NCT02119325
Acronym / sponsor ID: 202180
Conditions: Impaired Fasting Glucose
Keywords: fibre, overweight, impaired fasting glucose
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Oct 2013 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 15 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Test	Experimental	Dietary Supplement: 25% fibreFibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water
Placebo	Placebo comparator	Dietary Supplement: 0% fibreNo Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
25% fibreTest is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)	Dietary supplement	Test
0% fibrePlacebo is an energy matched powdered beverage	Dietary supplement	Placebo

Primary outcome

Cmax for Glucose in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
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)
Cmax for Triglyceride in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG

18 secondary outcomes

Cmax for Glucose in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for Glucose in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for Glucose in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Cmax for Triglyceride in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for Triglycerides in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for Triglycerides in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Cmax for RLP Cholesterol in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for RLP Cholesterol in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for RLP Cholesterol in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Cmax for RLP Cholesterol in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for RLP Cholesterol in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for RLP Cholesterol in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Cmax for Insulin in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for Insulin in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for Insulin in IFG Status Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Cmax for Insulin in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
AUC for Insulin in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Tmax for Insulin in Overweight Healthy Participants
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	48	48
Sequence 2	48	48

Primary outcome: Cmax for Glucose in IFG Status Participants

Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes. Mean (Standard Deviation). Unit: mg/dL

Measure	Test n = 26	Placebo n = 26
Value	42.76 (24.229)	47.40 (23.233)

Test vs Placebo: Difference in Adjusted Mean: -4.64 (95% CI -9.26 to -0.03), p = 0.0487, ANOVA

Population analysed: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

Primary outcome: Cmax for Triglyceride in IFG Status Participants

Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes. Mean (Standard Deviation). Unit: mg/dL

Measure	Test n = 26	Placebo n = 26
Value	121.07 (46.484)	127.85 (72.565)

Test vs Placebo: Difference in Adjusted Mean: -6.79 (95% CI -34.02 to 20.44), p = 0.6116, ANOVA

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the start of the investigational product, and until one day following last administration of the investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 96 (0%)	0 of 96 (0%)	Not reported
Placebo	0 of 96 (0%)	1 of 96 (1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Impaired Fasting Glucose

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Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 25% fibre and 0% fibre in people with Impaired Fasting Glucose, run by GlaxoSmithKline at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax for Glucose in IFG Status Participants (time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.