Tea-beetroot-venous Occlusion Plethysmography

Unilever

Status: Completed

Conditions: Insulin Resistance; Obesity

Treatments: Other: Beet root; Other: Tea; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01746329

Arnhem-Nijmegen 2012/357 (Other Identifier)

FDS-BNH-0809

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups, including a placebo group

Tea

Experimental group

Description:

Oral intake of tea containing 75 grams of glucose

Treatment:

Other: Tea

Beet root

Experimental group

Description:

Oral intake of beetroot juice containing 75 grams of glucose

Treatment:

Other: Beet root

Placebo

Placebo Comparator group

Description:

Oral intake of 75 grams of glucose in water

Treatment:

Other: Placebo