Tea-beetroot-venous Occlusion Plethysmography

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01746329
First received: November 30, 2012
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Insulin Resistance
Obesity
Other: Tea
Other: Beet root
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure


Secondary Outcome Measures:
  • echo-Doppler [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ] [ Designated as safety issue: No ]
    Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery

  • Near-infrared spectroscopy [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ] [ Designated as safety issue: No ]
    Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm

  • Glucose and insulin [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ] [ Designated as safety issue: No ]
    Glucose and insulin in venous blood plasma

  • Vascular resistance exploratory [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ] [ Designated as safety issue: No ]
    Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.


Enrollment: 18
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746329

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Unilever R&D
Radboud University
Investigators
Principal Investigator: M Hopman, Prof DR Radboud University
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01746329     History of Changes
Other Study ID Numbers: FDS-BNH-0809, Arnhem-Nijmegen 2012/357
Study First Received: November 30, 2012
Last Updated: August 2, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Unilever R&D:
Obesity, insulin resistance, muscle perfusion

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014