Post-prandial Glucose in Healthy Indian Subjects

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: plant-based dietary supplement; Other: Placebo

• Registration Number: NCT01999543
• Lead Sponsor: Unilever R&D

Brief Summary

The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Willing to give consent to participate in the study in writing;
• Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
• Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
• Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
• Willing to comply to study protocol during the study;
• Agreeing to be informed about medically relevant personal test-results by study physician;
• Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
• Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
• Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive)

Exclusion Criteria

• Being an employee of Unilever or CRO;
• Chronic smokers, tobacco chewers and drinkers;
• Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
• Use of medication which interferes with study measurements including vitamins, tonics;
• Reported intense exercise ≥10 h/week;
• Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
• Blood donation for 2 months prior to screening;
• Urine analysis that showed any drug abuse;
• Allergy to any food or cosmetics;
• If female, not being pregnant or planning pregnancy during the study period;
• If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference food format	plant-based dietary supplement	reference food format with and without plant-based ingredient added
Reference food format	Placebo	reference food format with and without plant-based ingredient added
Food format one	plant-based dietary supplement	Food format one with and without plant-based ingredient added
Food format one	Placebo	Food format one with and without plant-based ingredient added
Food format two	plant-based dietary supplement	Food format two with and without plant-based ingredient added
Food format two	Placebo	Food format two with and without plant-based ingredient added
Food format three	plant-based dietary supplement	Food format three with and without plant-based ingredient added
Food format three	Placebo	Food format three with and without plant-based ingredient added

Primary Outcome Measures

Name	Time	Method
Positive incremental post-prandial blood glucose area under the curve	120 minutes

Secondary Outcome Measures

Name	Time	Method
Post-prandial insulin area under the curve	120 minutes

Trial Locations

Locations (1)

Lambda Therapeutics Research Ltd (LTRL); 🇮🇳 Ahemdabad, India