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Tea-beetroot-venous Occlusion Plethysmography

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ClinicalTrials.gov Identifier: NCT01746329
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : August 5, 2013
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Unilever R&D

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

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Other: Tea Other: Beet root Other: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. echo-Doppler [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ]
    Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery

  2. Near-infrared spectroscopy [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ]
    Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm

  3. Glucose and insulin [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ]
    Glucose and insulin in venous blood plasma

  4. Vascular resistance exploratory [ Time Frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake ]
    Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01746329     History of Changes
Other Study ID Numbers: FDS-BNH-0809
Arnhem-Nijmegen 2012/357 ( Other Identifier: Commissie Mensgebonden Onderzoek )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases