Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

Unilever

Status: Completed

Conditions: Healthy

Treatments: Other: Natural fruit extract; Other: Assumed active; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02599740

FDS-NAA-2093

Details and patient eligibility

About

This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

Full description

The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

Enrollment: 84 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
• Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] and inflammatory diseases).
• Fasting blood glucose value of subjects is ≥ 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 within 14 days before day 1 except for both paracetamol and hormonal contraception.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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84 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Rice only

Treatment:

Other: Placebo

Assumed active

Active Comparator group

Description:

Assumed key active consumed with rice

Treatment:

Other: Assumed active

Natural fruit extract

Active Comparator group

Description:

Natural fruit extract consumed with rice

Treatment:

Other: Natural fruit extract