NCT03659890

Brief Summary

Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the building blocks for ATP, the sugar ribose has been suggested to be rate limiting for synthesising ATP. Previous studies have shown a decrease in ATP levels in the muscle after intense exercise, and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or ribose supplementation on exercise performance. However, any potential link between ATP metabolism and exercise performance has not been explored. This study will look at the effects of nucleotide and nucleotide-ribose supplementation in fuel utilisation and performance in skeletal muscle during endurance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

June 13, 2018

Last Update Submit

March 25, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Changes in muscle ATP concentrations

    After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery

Secondary Outcomes (4)

  • Changes in muscle glycogen concentrations

    After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery

  • Blood lactate concentrations

    After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise

  • Blood glucose concentrations

    After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise

  • Serum uric acid concentrations

    Measured at baseline and of days 6, 8 and 15 of each supplementation cycle

Study Arms (3)

Low nucleotide

PLACEBO COMPARATOR

2 week supplementation with a low nucleotide mycoprotein drink, with added dextrose

Dietary Supplement: Low nucleotide

High nucleotide

EXPERIMENTAL

2 week supplementation with a high nucleotide mycoprotein drink, with added dextrose

Dietary Supplement: High nucleotide

High nucletide + Ribose

EXPERIMENTAL

2 week supplementation with a high nucleotide mycoprotein drink, with added ribose

Dietary Supplement: High nucletide + Ribose

Interventions

Low nucleotideDIETARY_SUPPLEMENT

2 week, twice daily, supplementation with a nucleotide-depleted mycoprotein drink, with added dextrose

Low nucleotide
High nucleotideDIETARY_SUPPLEMENT

2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added dextrose

High nucleotide
High nucletide + RiboseDIETARY_SUPPLEMENT

2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added ribose

High nucletide + Ribose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18 and 30

You may not qualify if:

  • On medication (except contraception)
  • Smokers
  • Diagnosed with any metabolic or cardiovascular conditions
  • Muscle or bone injuries
  • BMI \< 18 or \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter - St Luke's Campus

Exeter, Devon, EX2 4TH, United Kingdom

Location

MeSH Terms

Interventions

High-Throughput Nucleotide SequencingRibose

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative TechniquesPentosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

September 6, 2018

Study Start

June 28, 2018

Primary Completion

February 2, 2020

Study Completion

February 2, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)