Effects of Dietary Ingredients on Vascular Function

Study Overview
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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.

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

Conditions
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Vascular Diseases, Impaired Glucose Tolerance

Intervention / Treatment
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* Dietary Supplement: A capsule containing both polyphenols and carotenoids
* Dietary Supplement: Placebo intervention


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary ingredients: polyphenols and carotenoids<br>Dietary ingredients: polyphenols and carotenoids | Dietary Supplement: A capsule containing both polyphenols and carotenoids<br> <br> |
| Placebo Comparator: Placebo product<br>Placebo product | Dietary Supplement: Placebo intervention<br>* Placebo intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 (IL-6) levels. |  | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory and oxidative stress biomarkers | Luminex HS cytokine, CVD, ADK and MMP panel Endothelial derived factors Systemic inflammatory cytokines: hsTNFα Systemic inflammatory cytokines: hsCRP Endothelial cell function markers Oxidative stress parameters | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | 
| Cell stress-defence responses | Direct & indirect markers of cell defence activation Inflammatory and oxidative stress markers Established and exploratory cardiovascular health markers | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | 
| Clinical chemistry parameters | Glucose & Insulin Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins & HbA1C. | At baseline (after run-in period of 2 weeks) and after 4 weeks intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress