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

Sponsor
Liverpool John Moores University (Other)
Overall Status
Completed
CT.gov ID
NCT04370353
Collaborator
(none)
18
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2
14.2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cocoa flavanols
  • Dietary Supplement: Placebo supplement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Investigating the Impact of Cocoa Flavanol Supplementation on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jun 7, 2019
Actual Study Completion Date :
Jun 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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.

Dietary Supplement: Placebo supplement
Microcrystalline filler, containing 0mg total flavanols.

Experimental: 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.

Dietary Supplement: Cocoa flavanols
Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.

Outcome Measures

Primary Outcome Measures

  1. Oxygen uptake kinetics [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.

  2. Exercise tolerance [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.

Secondary Outcome Measures

  1. 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).]

    Heart rate will be measured during moderate and severe-intensity exercise bouts, by short-range telemetry.

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

    Systolic and diastolic blood pressure will be assessed following 10 min of seated rest using an automated sphygmomanometer

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

    A finger prick blood sample will be taken to measure blood lactate pre- and post-exercise of each transition using a hand-held automated blood lactate analyser

  4. Physical activity and sedentary behaviour [Over 3 week period (In the 6 days preceding experimental testing)]

    Physical activity levels will be assessed in the 6 days prior to visiting the laboratory by an accelerometer, worn on the hip during waking hours.

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

    Perceived mental workload will be measured pre and post exercise using NASA Task Load Index and BORG rating of perceived exertion scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 55 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Institute for Sport & Exercise Sciences Liverpool United Kingdom

Sponsors and Collaborators

  • Liverpool John Moores University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liverpool John Moores University
ClinicalTrials.gov Identifier:
NCT04370353
Other Study ID Numbers:
  • 18/SPS/014
First Posted:
Apr 30, 2020
Last Update Posted:
Apr 30, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 30, 2020