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Clinical Trials/NCT04370353
NCT04370353CompletedNot Applicable

Investigating the Impact of Cocoa Flavanol Supplementation on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults

Liverpool John Moores University1 site in 1 country18 target enrollmentStarted: April 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Exercise tolerance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
35 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • •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

Arms & Interventions

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.

Intervention: Placebo supplement (Dietary 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.

Intervention: Cocoa flavanols (Dietary Supplement)

Outcomes

Primary Outcomes

Exercise tolerance

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

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.

Oxygen uptake kinetics

Time Frame: 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)

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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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