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

NCT ID: NCT02256332

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

Low dose plant based ingredient

Reference food with low dose of plant based ingredient

Group Type: ACTIVE_COMPARATOR

Low dose plant based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Reference food with low dose of plant based ingredient

High dose plant based ingredient

Reference food with high dose of plant based ingredient

Group Type: ACTIVE_COMPARATOR

High dose plant based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Reference food with high dose of plant based ingredient

Reference food format

Reference food without plant-based ingredient

Group Type: PLACEBO_COMPARATOR

Reference food format

Intervention Type: DIETARY_SUPPLEMENT

Reference food without plant-based ingredient

Interventions

Low dose plant based ingredient

Reference food with low dose of plant based ingredient

Intervention Type: DIETARY_SUPPLEMENT

High dose plant based ingredient

Reference food with high dose of plant based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Reference food format

Reference food without plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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)

Dr Shrikant V Deshpande

Role: PRINCIPAL_INVESTIGATOR

Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

Locations

Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

Thāne, Maharashtra, India

Lambda Therapeutics Research Ttd (LTRL)

Ahemdabad, , India

Countries

India

Other Identifiers

FDS-NAA-1633

Identifier Type: -

Identifier Source: org_study_id