Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects

Unilever R&D1 site in 1 country18 target enrollmentDecember 2012

ConditionsInsulin Resistance Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insulin Resistance
Sponsor: Unilever R&D
Enrollment: 18
Locations: 1
Primary Endpoint: Vascular resistance
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Unilever R&D

Responsible Party

Sponsor

Eligibility Criteria

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)