Impaired Glucose Tolerance, Vascular Diseases
Conditions
Keywords
Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTA capsule containing both polyphenols and carotenoids
DIETARY_SUPPLEMENTPlacebo intervention
Placebo intervention
Sponsors
Aspect Clinical
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin-6 (IL-6) levels. | At baseline (after 2 weeks run-in period) and after 4 weeks intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pro-inflammatory and oxidative stress biomarkers | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | * 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 |
| Cell stress-defence responses | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | * Direct & indirect markers of cell defence activation * Inflammatory and oxidative stress markers * Established and exploratory cardiovascular health markers |
| Clinical chemistry parameters | At baseline (after run-in period of 2 weeks) and after 4 weeks intervention | * Glucose & Insulin * Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins & HbA1C. |
Countries
United Kingdom
Outcome results
None listed