Post-prandial Glucose in Healthy Indian Subjects

Unilever

Status: Completed

Conditions: Healthy Subjects

Treatments: Dietary Supplement: plant-based dietary supplement; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01999543

FDS-NAA-1373

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

Reference food format

Other group

Description:

reference food format with and without plant-based ingredient added

Treatment:

Other: Placebo

Dietary Supplement: plant-based dietary supplement

Food format one

Experimental group

Description:

Food format one with and without plant-based ingredient added

Treatment:

Other: Placebo

Dietary Supplement: plant-based dietary supplement

Food format two

Experimental group

Description:

Food format two with and without plant-based ingredient added

Treatment:

Other: Placebo

Dietary Supplement: plant-based dietary supplement

Food format three

Experimental group

Description:

Food format three with and without plant-based ingredient added

Treatment:

Other: Placebo

Dietary Supplement: plant-based dietary supplement