Effects of Dietary Ingredients on Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Diseases Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dietary ingredients: polyphenols and carotenoids

Group Type ACTIVE_COMPARATOR

A capsule containing both polyphenols and carotenoids

Intervention Type DIETARY_SUPPLEMENT

Placebo product

Group Type PLACEBO_COMPARATOR

Placebo intervention

Intervention Type DIETARY_SUPPLEMENT

Placebo intervention

Interventions

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A capsule containing both polyphenols and carotenoids

Intervention Type DIETARY_SUPPLEMENT

Placebo intervention

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No