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Completed

NCT Number: NCT02119325

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

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.

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Key information

Conditions

Impaired Fasting Glucose Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, 380 061, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

25% fibre

Dietary Supplement

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

0% fibre

Dietary Supplement

Placebo is an energy matched powdered beverage

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

    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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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

    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

  8. 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

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

  9. 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

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

  10. 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

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

  11. 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

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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

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

  16. 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

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

  17. 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

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

  18. 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

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
Apr 21, 2014
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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