Effects of Dietary Ingredients on Vascular Function

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

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 Overview

• Status: Completed
• Conditions: Vascular Diseases; Impaired Glucose Tolerance
• Intervention / Treatment: Dietary supplement: A capsule containing both polyphenols and carotenoids; Dietary supplement: Placebo intervention

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ledbury, United Kingdom
    • Aspect Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo product	Dietary supplement: Placebo intervention; Placebo intervention
Active Comparator: Dietary ingredients: polyphenols and carotenoids	Dietary supplement: A capsule containing both polyphenols and carotenoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Aspect Clinical
• Investigators: Principal Investigator: Alex Thompson, Dr, Aspect Clinical

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Oxidative stress; Vascular function; Dietary ingredients; Acute glucose load
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Vascular Diseases; Glucose Intolerance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Carotenoids
• Other Study ID Numbers: FDS-BNH-0751