Effects of Dietary Ingredients on Vascular Function

Unilever

Status

Completed

Conditions

Impaired Glucose Tolerance

Vascular Diseases

Treatments

Dietary Supplement: Placebo intervention

Dietary Supplement: A capsule containing both polyphenols and carotenoids

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02158481

FDS-BNH-0751

Details and patient eligibility

About

The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.

The study will be conducted in subjects with impaired glucose tolerance.

Enrollment

50 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females confirmed with IGT;
Age ≥ 35 and ≤ 65 year at screening;
Body Mass Index (BMI) > 25 and <40 kg/m2;
Reported intense sporting activities ≤ 10h/w;
Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
Currently not smoking and being a non-smoker for at least six months

Exclusion criteria

Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
No reported participation in another nutritional or biomedical trial 3 months before screening;
Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
Anti-hyperglycemic drug or other medication which interferes with study measurements;
No blood donation 1 month prior to screening;
Reported allergy or intolerance to test products or other food products provided during the study;