NCT01302639

Brief Summary

There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. We hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. The following objective will be addressed in the current study: (1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects

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 Feb 2011

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

February 22, 2011

Last Update Submit

September 8, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • postprandial fat oxidation

    3 day supplementation of different combinations of polyphenols in a randomised crossover design in healthy overweight volunteers. At the end of each supplementation period, postprandial fat oxidation is measured

    3 days

Study Arms (3)

EGCG and resveratrol

EXPERIMENTAL
Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation

EGCG, resveratrol and genistein

EXPERIMENTAL
Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation

placebo

PLACEBO COMPARATOR
Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation

Interventions

EGCG, resveratol and genistein

EGCG and resveratrolEGCG, resveratrol and genisteinplacebo

Eligibility Criteria

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

You may not qualify if:

  • women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption \> 300 mg/day, alcohol intake \>20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

Related Publications (1)

  • Most J, Goossens GH, Jocken JW, Blaak EE. Short-term supplementation with a specific combination of dietary polyphenols increases energy expenditure and alters substrate metabolism in overweight subjects. Int J Obes (Lond). 2014 May;38(5):698-706. doi: 10.1038/ijo.2013.231. Epub 2013 Dec 9.

MeSH Terms

Conditions

ObesityInsulin ResistanceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 24, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations