Tea-beetroot-venous Occlusion Plethysmography

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746329
• Other study ID #: FDS-BNH-0809
• Secondary ID: Arnhem-Nijmegen
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: August 2, 2013
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male sex

• 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/m2.

• Presence of cardiovascular disease.

• Presence of sudden cardiac death in a 1st degree relative at an age <50 years.

• Presence of diabetes mellitus type 2.

• Regular tea drinker (> 2 cups per day)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Other:
• Tea
Oral intake of tea containing 75 grams of glucose
• Beet root
Oral intake of beetroot juice containing 75 grams of glucose
• Placebo
Oral intake of 75 grams of glucose in water

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular resistance	Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure	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)	No
Secondary	echo-Doppler	Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery	Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake	No
Secondary	Near-infrared spectroscopy	Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm	Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake	No
Secondary	Glucose and insulin	Glucose and insulin in venous blood plasma	Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake	No
Secondary	Vascular resistance exploratory	Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.	Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake	No