Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Reference food format; Dietary Supplement: Low dose plant based ingredient; Dietary Supplement: High dose plant based ingredient

• Registration Number: NCT02256332
• Lead Sponsor: Unilever R&D

Brief Summary

Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

Detailed Description

The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-03
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
• Age ≥ 20 and ≤ 65 year at screening;
• Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
• HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.

Exclusion Criteria

• Being an employee of Unilever or research site;
• Chronic smokers, tobacco chewers and drinkers;
• No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
• Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
• 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference food format	Reference food format	Reference food without plant-based ingredient
Low dose plant based ingredient	Low dose plant based ingredient	Reference food with low dose of plant based ingredient
High dose plant based ingredient	High dose plant based ingredient	Reference food with high dose of plant based ingredient

Primary Outcome Measures

Name	Time	Method
Post prandial blood glucose positive incremental area under the curve	120 minutes

Secondary Outcome Measures

Name	Time	Method
Post prandial insulin area under the curve	120 minutes

Trial Locations

Locations (2)

Lambda Therapeutics Research Ttd (LTRL); 🇮🇳 Ahemdabad, India

Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA; 🇮🇳 Thane, Maharashtra, India