NCT02119325

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 15, 2015

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

April 17, 2014

Results QC Date

June 5, 2014

Last Update Submit

May 11, 2015

Conditions

Impaired Fasting Glucose

Keywords

fibreoverweightimpaired fasting glucose

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    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

    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

    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

    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

    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

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

  • +13 more secondary outcomes

Study Arms (2)

Test

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

25% fibreDIETARY_SUPPLEMENT

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

Test
0% fibreDIETARY_SUPPLEMENT

Placebo is an energy matched powdered beverage

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, 380 061, India

Location

MeSH Terms

Conditions

Overweight

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 21, 2014

Study Start

September 1, 2013

Primary Completion

October 1, 2013

Last Updated

May 15, 2015

Results First Posted

May 15, 2015

Record last verified: 2015-04

Locations

IN(1)