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Tea-beetroot-venous Occlusion Plethysmography

Primary Purpose

Insulin Resistance, Obesity

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Tea

Beet root

Placebo

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Obesity, insulin resistance, muscle perfusion

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Tea

Beet root

Placebo

Arm Description

Oral intake of tea containing 75 grams of glucose

Oral intake of beetroot juice containing 75 grams of glucose

Oral intake of 75 grams of glucose in water

Outcomes

Primary Outcome Measures

Vascular resistance

Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure

Secondary Outcome Measures

echo-Doppler

Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery

Near-infrared spectroscopy

Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm

Glucose and insulin

Glucose and insulin in venous blood plasma

Vascular resistance exploratory

Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.

Full Information

NCT ID

NCT01746329

First Posted

November 30, 2012

Last Updated

August 2, 2013

Sponsor

Unilever R&D

Collaborators

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01746329

Brief Title

Tea-beetroot-venous Occlusion Plethysmography

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unilever R&D

Collaborators

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Obesity

Keywords

Obesity, insulin resistance, muscle perfusion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tea

Arm Type

Experimental

Arm Description

Oral intake of tea containing 75 grams of glucose

Arm Title

Beet root

Arm Type

Experimental

Arm Description

Oral intake of beetroot juice containing 75 grams of glucose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral intake of 75 grams of glucose in water

Intervention Type

Other

Intervention Name(s)

Tea

Intervention Description

Oral intake of tea containing 75 grams of glucose

Intervention Type

Other

Intervention Name(s)

Beet root

Intervention Description

Oral intake of beetroot juice containing 75 grams of glucose

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Oral intake of 75 grams of glucose in water

Primary Outcome Measure Information:

Title

Vascular resistance

Description

Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure

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)

Secondary Outcome Measure Information:

Title

echo-Doppler

Description

Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery

Time Frame

Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake

Title

Near-infrared spectroscopy

Description

Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm

Time Frame

Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake

Title

Glucose and insulin

Description

Glucose and insulin in venous blood plasma

Time Frame

Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake

Title

Vascular resistance exploratory

Description

Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.

Time Frame

Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M Hopman, Prof DR

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6500 HB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

27182277

Citation

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.

Results Reference

derived

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Tea-beetroot-venous Occlusion Plethysmography

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