Post-prandial Glucose in Healthy Indian Subjects

NCT ID: NCT01999543

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-02-28

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Reference food format

reference food format with and without plant-based ingredient added

Group Type: OTHER

plant-based dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Food format one

Food format one with and without plant-based ingredient added

Group Type: EXPERIMENTAL

plant-based dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Food format two

Food format two with and without plant-based ingredient added

Group Type: EXPERIMENTAL

plant-based dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Food format three

Food format three with and without plant-based ingredient added

Group Type: EXPERIMENTAL

plant-based dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Interventions

plant-based dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Ketul Modi, MBBS

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutics Research Ltd (LTRL)

Locations

Lambda Therapeutics Research Ltd (LTRL)

Ahemdabad, , India

Countries

India

Other Identifiers

FDS-NAA-1373

Identifier Type: -

Identifier Source: org_study_id