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

Unilever

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Low dose plant based ingredient; Dietary Supplement: Reference food format; Dietary Supplement: High dose plant based ingredient

Study type: Interventional

Funder types: Industry

Identifiers

NCT02256332

FDS-NAA-1633

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

Low dose plant based ingredient

Active Comparator group

Description:

Reference food with low dose of plant based ingredient

Treatment:

Dietary Supplement: Low dose plant based ingredient

High dose plant based ingredient

Active Comparator group

Description:

Reference food with high dose of plant based ingredient

Treatment:

Dietary Supplement: High dose plant based ingredient

Reference food format

Placebo Comparator group

Description:

Reference food without plant-based ingredient

Treatment:

Dietary Supplement: Reference food format