Post-prandial Glucose in Healthy Subjects

Effect of Different Levels of Plant-based Ingredients on Post-prandial Glucose in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: no added plant-based ingredients to starchy meal; Dietary supplement: Low level plant-based ingredients added to starchy meal; Dietary supplement: Medium level plant-based ingredients added to starchy meal; Dietary supplement: High level plant-based ingredients added to starchy meal

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India
    • Lambda Therapeutics Research Ltd (LTRL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Reference; no added plant-based ingredients	Dietary supplement: no added plant-based ingredients to starchy meal; no added plant-based ingredients to starchy meal
Active Comparator: Low level plant-based ingredients; Low level addition of plant-based ingredients	Dietary supplement: Low level plant-based ingredients added to starchy meal; Low level plant-based ingredients added to starchy meal
Active Comparator: Medium level plant-based ingredients; Medium level addition of plant-based ingredients	Dietary supplement: Medium level plant-based ingredients added to starchy meal; Medium level plant-based ingredients added to starchy meal
Active Comparator: High level plant-based ingredients; High level addition of plant-based ingredients	Dietary supplement: High level plant-based ingredients added to starchy meal; High level plant-based ingredients added to starchy meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-prandial blood glucose area under the curve	120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-prandial insulin area under the curve	120 minutes

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Dr Ketul Modi, MBBS, Lambda Therapeutics Research Ltd (LTRL)

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: October 4, 2013
• First Posted (Estimate): October 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Blood glucose
• Other Study ID Numbers: FDS-NAA-1335