Back to resultsEffects of Dietary Ingredients on Vascular Function
Primary Purpose
Vascular Diseases, Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
A capsule containing both polyphenols and carotenoids
Placebo intervention
Sponsored by
About this trial
This is an interventional basic science trial for Vascular Diseases focused on measuring Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress
Eligibility Criteria
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;
Sites / Locations
- Aspect Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dietary ingredients: polyphenols and carotenoids
Placebo product
Arm Description
Dietary ingredients: polyphenols and carotenoids
Placebo product
Outcomes
Primary Outcome Measures
Interleukin-6 (IL-6) levels.
Secondary Outcome Measures
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
Cell stress-defence responses
Direct & indirect markers of cell defence activation
Inflammatory and oxidative stress markers
Established and exploratory cardiovascular health markers
Clinical chemistry parameters
Glucose & Insulin
Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins & HbA1C.
Full Information
NCT ID
NCT02158481
First Posted
March 24, 2014
Last Updated
June 23, 2015
Sponsor
Unilever R&D
Collaborators
Aspect Clinical
1. Study Identification
Unique Protocol Identification Number
NCT02158481
Brief Title
Effects of Dietary Ingredients on Vascular Function
Official Title
Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
Aspect Clinical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Impaired Glucose Tolerance
Keywords
Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary ingredients: polyphenols and carotenoids
Arm Type
Active Comparator
Arm Description
Dietary ingredients: polyphenols and carotenoids
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
Placebo product
Intervention Type
Dietary Supplement
Intervention Name(s)
A capsule containing both polyphenols and carotenoids
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo intervention
Intervention Description
Placebo intervention
Primary Outcome Measure Information:
Title
Interleukin-6 (IL-6) levels.
Time Frame
At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary Outcome Measure Information:
Title
Pro-inflammatory and oxidative stress biomarkers
Description
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
Time Frame
At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Title
Cell stress-defence responses
Description
Direct & indirect markers of cell defence activation
Inflammatory and oxidative stress markers
Established and exploratory cardiovascular health markers
Time Frame
At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Title
Clinical chemistry parameters
Description
Glucose & Insulin
Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins & HbA1C.
Time Frame
At baseline (after run-in period of 2 weeks) and after 4 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Thompson, Dr
Organizational Affiliation
Aspect Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aspect Clinical
City
Ledbury
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effects of Dietary Ingredients on Vascular Function
We'll reach out to this number within 24 hrs