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OpenTrials
Completed

NCT Number: NCT02158481

Effects of Dietary Ingredients on Vascular Function

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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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aspect Clinical

Ledbury, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

A capsule containing both polyphenols and carotenoids

Dietary Supplement

Placebo intervention

Dietary Supplement

Placebo intervention

Primary outcomes

  1. Interleukin-6 (IL-6) levels.

    Time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Secondary outcomes

  1. Pro-inflammatory and oxidative stress biomarkers

    Time frame: 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
  2. Cell stress-defence responses

    Time frame: 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
  3. Clinical chemistry parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Aspect Clinical

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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