NCT01746329CompletedNot Applicable
Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
Unilever R&D2 sites in 1 country18 target enrollmentStarted: December 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Vascular resistance
Study Overview
Brief Summary
In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.
Detailed Description
Based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 30-70 years.
- •Obesity (BMI>30 kg/m2)
- •insulin resistance as fasting glucose levels >6.1 mmol/L.
- •Reported intense sport activities >10 h/w.
- •Reported alcohol consumption >28 units/w
- •Signed Informed consent
- •Currently not smoking and being a non-smoker for at least 3 months prior to the start of the study.
Exclusion Criteria
- •BMI ≥ 40 kg/m
- •Presence of cardiovascular disease.
- •Presence of sudden cardiac death in a 1st degree relative at an age <50 years.
- •Presence of diabetes mellitus type
- •Regular tea drinker (> 2 cups per day)
Outcomes
Primary Outcomes
Vascular resistance
Time Frame: Average of values obtained at 30, 60, 90, 120, 150 and 180 minutes after test product intake corrected for the value obtained at approximately 20 minutes before test product intake (baseline)
Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure
Secondary Outcomes
- echo-Doppler(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Near-infrared spectroscopy(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Glucose and insulin(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Vascular resistance exploratory(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
Investigators
Study Sites (2)
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