Effect of a Plant-based Ingredient on Glucose Response

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: No Plant-based ingredient; Dietary Supplement: Plant-based ingredient

• Registration Number: NCT02218528
• Lead Sponsor: Unilever R&D

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Starchy meal	No Plant-based ingredient	No Plant-based ingredient added to a starchy meal
Starchy meal and side dish	No Plant-based ingredient	No Plant-based ingredient added to starchy meal and side dish
High dose added to starchy meal and side dish	Plant-based ingredient	Plant-based ingredient in high dose added to starchy meal and side dish
Low dose added to starchy meal	Plant-based ingredient	Plant-based ingredient in low dose added to starchy meal
Low dose added to starchy meal and side dish	Plant-based ingredient	Plant-based ingredient in low dose added to starchy meal and side dish
Medium dose added to starchy meal and side dish	Plant-based ingredient	Plant-based ingredient in medium dose added to starchy meal and side dish

Primary Outcome Measures

Name	Time	Method
Positive incremental post-prandial blood glucose area unde the curve	120 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lambda Therapeutics Research Ltd (LTRL); 🇮🇳 Ahmedabad, India