The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

Unilever

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: fruit extract; Dietary Supplement: no added fruit extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388503

FDS-NAA-1946

Details and patient eligibility

About

This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
• Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
• Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.

Exclusion criteria

• Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
• Blood donation in the past 3 months and/or during the study.
• Reported intense sporting activities > 10 h/week.
• Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
• Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
• If female, is pregnant (or has been pregnant during the last < 3 months) or will be planning pregnancy during the study period.
• If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
• Dislike, known allergy or intolerance to test products or other food products provided during the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 5 patient groups, including a placebo group

Reference

Placebo Comparator group

Description:

No added fruit extract

Treatment:

Dietary Supplement: no added fruit extract

Active 1

Active Comparator group

Description:

lowest dose of fruit extract

Treatment:

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Active 2

Active Comparator group

Description:

low dose of fruit extract

Treatment:

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Active 3

Active Comparator group

Description:

medium dose of fruit extract

Treatment:

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Active 4

Active Comparator group

Description:

high dose of fruit extract

Treatment:

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract

Dietary Supplement: fruit extract