Healthy Subjects Clinical Trial
Official title:
Effect of Different Levels of Plant-based Ingredients on Post-prandial Glucose in Healthy Subjects
Verified date | November 2013 |
Source | Unilever R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Research Ethics committee |
Study type | Interventional |
The study is designed to determine the extent to which foods containing different levels of plant-based ingredients affect blood glucose responses in healthy subjects.
Status | Completed |
Enrollment | 84 |
Est. completion date | |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 50 Years |
Eligibility |
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) as judged by the research physician. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
India | Lambda Therapeutics Research Ltd (LTRL) | Ahmedabad |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-prandial blood glucose area under the curve | 120 minutes | No | |
Secondary | Post-prandial insulin area under the curve | 120 minutes | No |
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