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

NCT04370353 | Completed

• 1 other identifier: 18/SPS/014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Sedentary Behavior

Outcome Measures

Primary Outcomes (2)

• Oxygen uptake kinetics

  Oxygen uptake kinetics (including time constant, time delay and amplitude of the fundamental oxygen uptake response) will be determined by modelling oxygen uptake during exercise using a mono exponential function. The oxygen uptake data is measured on a breath-by-breath basis during exercise (on a cycle ergometer) using a gas analysis system and face mask. Oxygen kinetics will be measured during three moderate-intensity step exercise tests (at 80% of the gas exchange threshold) and during one severe-intensity (60%∆) step exercise test that is completed to failure.

  Over 3 week period (After 7 days of each intervention). Oxygen uptake measured for 9 minutes continuously during exercise bouts (3 min warm up period and 6 minutes of exercise transition)

• Exercise tolerance

  Participants capacity to exercise to the limit of tolerance, measured to the nearest second. Participants are instructed to exercise at a severe-intensity exercise load (representative of 60% ∆), on a cycle ergometer until volitional exhaustion.

  Over 3 week period (After 7 days of each intervention).

Secondary Outcomes (5)

• Heart rate

  Over 3 week period (After 7 days of each intervention). Measured during the length of each exercise transition (9 minutes for each moderate intensity bout).

• Blood pressure

  Over 3 week period (After 7 days of each intervention). Measured over 5 minutes before any exercise testing.

• Blood lactate

  Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise

• Physical activity and sedentary behaviour

  Over 3 week period (In the 6 days preceding experimental testing)

• Perceived workload

  Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo supplement

Cocoa Flavanols

EXPERIMENTAL

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.

Dietary Supplement: Cocoa flavanols

Interventions

Cocoa flavanols DIETARY_SUPPLEMENT

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

Cocoa Flavanols

Placebo supplement DIETARY_SUPPLEMENT

Microcrystalline filler, containing 0mg total flavanols.

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

Study Sites (1)

Research Institute for Sport & Exercise Sciences

Liverpool, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33970327 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: April 1, 2018
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

GB (1)