NCT01746329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

November 30, 2012

Last Update Submit

August 2, 2013

Conditions

Insulin ResistanceObesity

Keywords

Obesity, insulin resistance, muscle perfusion

Outcome Measures

Primary Outcomes (1)

  • Vascular resistance

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

    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 Outcomes (4)

  • echo-Doppler

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

  • Near-infrared spectroscopy

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

  • Glucose and insulin

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

  • Vascular resistance exploratory

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

Study Arms (3)

Tea

EXPERIMENTAL

Oral intake of tea containing 75 grams of glucose

Other: Tea

Beet root

EXPERIMENTAL

Oral intake of beetroot juice containing 75 grams of glucose

Other: Beet root

Placebo

PLACEBO COMPARATOR

Oral intake of 75 grams of glucose in water

Other: Placebo

Interventions

TeaOTHER

Oral intake of tea containing 75 grams of glucose

Tea
Beet rootOTHER

Oral intake of beetroot juice containing 75 grams of glucose

Beet root
PlaceboOTHER

Oral intake of 75 grams of glucose in water

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 27182277DERIVED

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

Tea

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • M Hopman, Prof DR

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 10, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

NL(1)