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Completed

NCT Number: NCT01746329

Tea-beetroot-venous Occlusion Plethysmography

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

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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tea

Other

Oral intake of tea containing 75 grams of glucose

Beet root

Other

Oral intake of beetroot juice containing 75 grams of glucose

Placebo

Other

Oral intake of 75 grams of glucose in water

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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