Trial | NCT02158481  Report issue

Title

Effects of Dietary Ingredients on Vascular Function
Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Apr 30
2014
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Jun 24
2015
Estimate

Dietary Supplement A capsule containing both polyphenols and carotenoids

Dietary Supplement Placebo intervention

Placebo intervention

Dietary ingredients: polyphenols and carotenoids Active Comparator

Dietary ingredients: polyphenols and carotenoids

Placebo product Placebo Comparator

Placebo product

Criteria 

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;
No Results Posted