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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370353
• Other study ID #: 18/SPS/014
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: April 2020
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Sedentary Behavior

Intervention

Dietary Supplement:
• Cocoa flavanols
Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.
• Placebo supplement
Microcrystalline filler, containing 0mg total flavanols.

Locations

Country	Name	City	State
United Kingdom	Research Institute for Sport & Exercise Sciences	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Heart rate	Heart rate will be measured during moderate and severe-intensity exercise bouts, by short-range telemetry.	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).
Secondary	Blood pressure	Systolic and diastolic blood pressure will be assessed following 10 min of seated rest using an automated sphygmomanometer	Over 3 week period (After 7 days of each intervention). Measured over 5 minutes before any exercise testing.
Secondary	Blood lactate	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	Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise
Secondary	Physical activity and sedentary behaviour	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.	Over 3 week period (In the 6 days preceding experimental testing)
Secondary	Perceived workload	Perceived mental workload will be measured pre and post exercise using NASA Task Load Index and BORG rating of perceived exertion scale.	Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise