Effect of a Plant-based Ingredient on Glucose Response

An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal

The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: No Plant-based ingredient; Dietary supplement: Plant-based ingredient

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
• Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
• Fasting blood glucose value of subjects 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;
• Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
• Agreeing to be informed about medically relevant personal test-results by study physician;
• Willing to comply to study protocol during study;
• Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
• Accessible veins on arms as determined by examination at screening;
• Being literate;
• HbA1C ≤ 6.5 % (48 mmol/mol).

Exclusion Criteria:

• Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
• Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
• Blood donation in the past 2 months;
• Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
• Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
• Reported intense sporting activities > 10h/w;
• Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
• Drug abuse as indicated by urine analysis;
• Chronic smokers, tobacco chewers and drinkers;
• Use of any medication, including supplements and traditional medicine;
• Reported dietary habits, such as a medically prescribed/slimming diet;
• Not being used to eat breakfast;
• Reported weight loss/gain (>10%) in the last six month before the study;
• Being an employee of Unilever or CRO;
• Allergy or intolerance to food products and aversion to food products provided during the study;
• If female: pregnant or will be planning pregnancy during the study period;
• If female: lactating or has been lactating in the 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: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dose added to starchy meal; Plant-based ingredient in low dose added to starchy meal	Dietary supplement: Plant-based ingredient
Placebo Comparator: Starchy meal; No Plant-based ingredient added to a starchy meal	Dietary supplement: No Plant-based ingredient
Placebo Comparator: Starchy meal and side dish; No Plant-based ingredient added to starchy meal and side dish	Dietary supplement: No Plant-based ingredient
Active Comparator: Low dose added to starchy meal and side dish; Plant-based ingredient in low dose added to starchy meal and side dish	Dietary supplement: Plant-based ingredient
Active Comparator: Medium dose added to starchy meal and side dish; Plant-based ingredient in medium dose added to starchy meal and side dish	Dietary supplement: Plant-based ingredient
Active Comparator: High dose added to starchy meal and side dish; Plant-based ingredient in high dose added to starchy meal and side dish	Dietary supplement: Plant-based ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive incremental post-prandial blood glucose area unde the curve	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive incremental post-prandial blood glucose area under the curve		180 minutes
Post-prandial insulin response		120 minutes
Post-prandial insulin response		180 minutes
Assessment of gastric emptying rate	GE50% (time to empty 50% of the gastric content) will be determined with paracetamol	10 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	peak plasma glucose	120 minutes
Cmax-baseline corrected	peak plasma glucose - baseline plasma glucose	120 minutes
Tmax	peak time plasma glucose	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: August 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: subjects
• Other Study ID Numbers: FDS-NAA-1716