Tea-beetroot-venous Occlusion Plethysmography

NCT ID: NCT01746329

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Insulin Resistance Obesity

Keywords

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Obesity, insulin resistance, muscle perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tea

Oral intake of tea containing 75 grams of glucose

Group Type EXPERIMENTAL

Tea

Intervention Type OTHER

Oral intake of tea containing 75 grams of glucose

Beet root

Oral intake of beetroot juice containing 75 grams of glucose

Group Type EXPERIMENTAL

Beet root

Intervention Type OTHER

Oral intake of beetroot juice containing 75 grams of glucose

Placebo

Oral intake of 75 grams of glucose in water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral intake of 75 grams of glucose in water

Interventions

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Tea

Oral intake of tea containing 75 grams of glucose

Intervention Type OTHER

Beet root

Oral intake of beetroot juice containing 75 grams of glucose

Intervention Type OTHER

Placebo

Oral intake of 75 grams of glucose in water

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M Hopman, Prof DR

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 27182277 (View on PubMed)

Other Identifiers

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Arnhem-Nijmegen 2012/357

Identifier Type: OTHER

Identifier Source: secondary_id

FDS-BNH-0809

Identifier Type: -

Identifier Source: org_study_id