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Impact of Cocoa Flavanols on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults

NCT ID: NCT04370353

Last Updated: 2020-04-30

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

2018-04-01

Study Completion Date

2019-06-07

Brief Summary

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In recent years, there has been significant interest in dietary flavonoids (biologically active plant-derived compounds) as potential therapeutics. This is due to the capacity of flavonoids to enhance processes related to energy metabolism and cardiovascular health. We are interested in implementing a short-term supplementation regime (daily cocoa-flavanoid ingestion), in order to explore the possible beneficial effects of flavonoid-based interventions on responses to exercise. Hence, the objective of our study is to examine the impact of short term cocoa-flavanoid supplementation on processes related to energy use (oxygen utilisation). Our aim is to develop a novel intervention which improves cardiovascular health and enhances exercise tolerance.

Detailed Description

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Conditions

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Aging Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo supplement, each capsule containing: 0mg total flavanols, matched for caffeine and theobromine content as experimental supplement (2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM after mixed meal for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline filler, containing 0mg total flavanols.

Cocoa Flavanols

Experimental supplement, each capsule containing: 316 mg CocoActiv (Naturex, Netherlands: 100mg total cocoa flavanols, 2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM) for 7 days.

Group Type EXPERIMENTAL

Cocoa flavanols

Intervention Type DIETARY_SUPPLEMENT

Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.

Interventions

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Cocoa flavanols

Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Microcrystalline filler, containing 0mg total flavanols.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Aged 35-55 years
* Healthy (no known cardiovascular or metabolic disorders e.g. diabetes)
* Do not engage in regular structured physical training (i.e. less than two sessions for 60 minutes per week, for at least 1 year

Exclusion Criteria

* Smokers
* Medical history of cardiovascular and/or metabolic disease, including diabetes and abnormal blood pressure
* Family history of cardiovascular disease
* Currently taking any medication
* Asthmatic
* Currently suffering from musculoskeletal injury
* Younger than 35 or older than 55 years old
* Known food allergies or special dietary requirements
* Currently taking any dietary supplements
* Currently engaging in \>2 hours structured training per week
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Institute for Sport & Exercise Sciences

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Sadler DG, Draijer R, Stewart CE, Jones H, Marwood S, Thijssen DHJ. Cocoa-flavanols enhance moderate-intensity pulmonary V O 2 kinetics but not exercise tolerance in sedentary middle-aged adults. Eur J Appl Physiol. 2021 Aug;121(8):2285-2294. doi: 10.1007/s00421-021-04682-9. Epub 2021 May 10.

Reference Type DERIVED
PMID: 33970327 (View on PubMed)

Other Identifiers

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18/SPS/014

Identifier Type: -

Identifier Source: org_study_id