Tea-beetroot-venous Occlusion Plethysmography

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Other: Tea; Other: Beet root; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tea; Oral intake of tea containing 75 grams of glucose	Other: Tea; Oral intake of tea containing 75 grams of glucose
EXPERIMENTAL: Beet root; Oral intake of beetroot juice containing 75 grams of glucose	Other: Beet root; Oral intake of beetroot juice containing 75 grams of glucose
PLACEBO_COMPARATOR: Placebo; Oral intake of 75 grams of glucose in water	Other: Placebo; Oral intake of 75 grams of glucose in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Radboud University Medical Center
• Investigators: Principal Investigator: M Hopman, Prof DR, Radboud University Medical Center

Publications and helpful links

General Publications

• Fuchs D, Nyakayiru J, Draijer R, Mulder TP, Hopman MT, Eijsvogels TM, Thijssen DH. Impact of flavonoid-rich black tea and beetroot juice on postprandial peripheral vascular resistance and glucose homeostasis in obese, insulin-resistant men: a randomized controlled trial. Nutr Metab (Lond). 2016 May 13;13:34. doi: 10.1186/s12986-016-0094-x. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Obesity, insulin resistance, muscle perfusion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: FDS-BNH-0809; Arnhem-Nijmegen 2012/357 (OTHER: Commissie Mensgebonden Onderzoek)