NCT03945916

Brief Summary

Nitrate supplements (beetroot juice, pure sodium nitrate) have become common among endurance athletes because the ingestion of exogenous nitrate leads to increased levels of nitric oxide (NO) in the body. Increased NO has been shown to have various performance enhancing effects such as increased muscle contractility, increased blood flow through vasodilation, mitochondrial biogenesis, and improved glucose uptake. Supplementation with exogenous forms of nitrate has also been shown to improve cycling performance in the oxygen deprived environment of simulated altitude through increased muscular oxygenation. Further research is emerging that suggests that dark chocolate (DC) may have similar effects through flavonoids, a bioactive micronutrient that increases the synthesis of NO and reduces the rate at which NO is removed from the blood. In addition to performance enhancement, the flavonoids in DC also have anti-inflammatory and antioxidant effects, which could reduce muscle damage after a bout of exercise and increase the rate at which the muscle recovers. The purpose of this research is to investigate the effects of DC on cycling performance and recovery in cyclists at altitude. it is hypothesised that the DC condition will result in superior metabolism during exercise and increase muscular oxygenation, leading to improved performance while enhancing recovery from exercise. Methods: 12 trained cyclists will be randomized to supplement with 160g of DC or an isocaloric placebo per day for 2 weeks in a cross-over study. After the 2-weeks of supplementation participants will attend a lab session in which they will cycle 90 minutes at 60% VO2max followed immediately by a 10km time trial (TT) at a simulated altitude of 1500m (15% O2). Plasma levels of blood glucose and lactate will be measured before, throughout, and after exercise while muscular and cerebral oxygenation will be measured continuously throughout exercise. Recovery of the knee extensors will be assessed before and immediately after exercise as well as 24 and 48 hours later by determining knee extensor strength and muscle pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

May 6, 2019

Last Update Submit

June 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 10 km time trial performance

    cycling exercise performance

    Measured on day 15 of dark chocolate/placebo consumption

Secondary Outcomes (7)

  • Glucose

    Change from baseline to 90 minutes of exercise

  • Lactate

    Change from baseline to 90 minutes of exercise

  • Muscle oxygenation

    Change from baseline to 90 minutes of exercise

  • Carbohydrate oxidation

    Change from baseline to 90 minutes of exercise

  • Fat oxidation

    Change from baseline to 90 minutes of exercise

  • +2 more secondary outcomes

Study Arms (2)

Dark chocolate

EXPERIMENTAL

180g/d dark chocolate

Dietary Supplement: Dark chocolate

Placebo

PLACEBO COMPARATOR

180g/d of artificial dark chocolate

Dietary Supplement: Placebo

Interventions

Dark chocolateDIETARY_SUPPLEMENT

180 g/d dark chocolate for 15 days followed by exercise testing

Dark chocolate
PlaceboDIETARY_SUPPLEMENT

Placebo: 180 g/d imitation dark chocolate for 15 days followed by exercise testing

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endurance-trained cyclists

You may not qualify if:

  • Regular consumption of dark chocolate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Regain, Faculty if Kinesiology and Health Sciences

Regina, Saskatchewan, S4S 0A2, Canada

Location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip Chilibeck, Ph.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover - dark chocolate vs. placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 10, 2019

Study Start

May 15, 2019

Primary Completion

August 30, 2019

Study Completion

October 1, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations