Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects

Unilever R&D1 site in 1 country120 target enrollmentNovember 2013

ConditionsHealthy Subjects

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: Unilever R&D
Enrollment: 120
Locations: 1
Primary Endpoint: Positive incremental post-prandial blood glucose area under the curve
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Unilever R&D

Responsible Party

Sponsor

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;