Effect of a Plant-based Ingredient on Glucose Response

NCT ID: NCT02218528

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Starchy meal

No Plant-based ingredient added to a starchy meal

Group Type: PLACEBO_COMPARATOR

No Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Low dose added to starchy meal

Plant-based ingredient in low dose added to starchy meal

Group Type: ACTIVE_COMPARATOR

Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Starchy meal and side dish

No Plant-based ingredient added to starchy meal and side dish

Group Type: PLACEBO_COMPARATOR

No Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Low dose added to starchy meal and side dish

Plant-based ingredient in low dose added to starchy meal and side dish

Group Type: ACTIVE_COMPARATOR

Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Medium dose added to starchy meal and side dish

Plant-based ingredient in medium dose added to starchy meal and side dish

Group Type: ACTIVE_COMPARATOR

Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

High dose added to starchy meal and side dish

Plant-based ingredient in high dose added to starchy meal and side dish

Group Type: ACTIVE_COMPARATOR

Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

No Plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Ketul Modi, MBBS

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutics Research Ltd (LTRL)

Locations

Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, , India

Countries

India

Other Identifiers

FDS-NAA-1716

Identifier Type: -

Identifier Source: org_study_id