Post-prandial Glucose in Healthy Indian Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999543
• Other study ID #: FDS-NAA-1373
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: February 21, 2014
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Research Ethics committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: February 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)

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• plant-based dietary supplement

Other:
• Placebo

Locations

Country	Name	City	State
India	Lambda Therapeutics Research Ltd (LTRL)	Ahemdabad

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive incremental post-prandial blood glucose area under the curve		120 minutes	No
Secondary	Post-prandial insulin area under the curve		120 minutes	No