Effects of Dietary Ingredients on Vascular Function

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance; Vascular Diseases
• Interventions: Dietary Supplement: Placebo intervention; Dietary Supplement: A capsule containing both polyphenols and carotenoids

• Registration Number: NCT02158481
• Lead Sponsor: Unilever R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study Start: 2014-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo product	Placebo intervention	Placebo product
Dietary ingredients: polyphenols and carotenoids	A capsule containing both polyphenols and carotenoids	Dietary ingredients: polyphenols and carotenoids

Primary Outcome Measures

Name	Time	Method
Interleukin-6 (IL-6) levels.	At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aspect Clinical; 🇬🇧 Ledbury, United Kingdom