NCT07122778

Brief Summary

Recent research has suggested that increasing levels of physical activity are associated with a reduction in the independent components that contribute to total energy expenditure (such as resting metabolic rate and non-exercise movement) - this occurs to conserve energy required for physical activity where energy provision becomes scarce. There are potential deleterious health and performance consequences of a reduced energy supply to fundamental metabolic processes, putting individuals regularly undertaking high levels of physical activity, such as endurance athletes, at risk. However, this association is largely based on observational data in only moderately active populations, and it is currently unclear what role energy balance status and biological sex has on this relationship. This research intends to address these unknowns by assessing the impact of diet-induced manipulation of energy balance (conditions of energy deficit and energy surplus) in individuals undertaking habitually high levels of physical activity on independent components of total energy expenditure (resting metabolism, exercise and non-exercise movement). Male and female athletes conducting regular moderate-to-high training volumes will undertake a randomised crossover study with a 7-day state of energy deficit and a 7-day state of energy surplus. Participants will continue to live and train as normal, but their diet will be controlled by specific food provision over the intervention periods in order to facilitate both conditions. Independent components of energy expenditure, markers of health, metabolism and performance will be measured to allow for comparison of conditions.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress44%
Aug 2025May 2027

First Submitted

Initial submission to the registry

April 14, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

April 14, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

energy deficitenergy balanceenergy availabilityphysical activity

Outcome Measures

Primary Outcomes (1)

  • Resting metabolic rate (RMR) in kcal/day

    The effect of a 7-day period of energy expenditure-matched diet-induced energy deficit versus energy surplus on RMR. Measured via indirect calorimetry using the Douglas bag method. Expired gas will be collected in a seated, fasted state under thermoneutral conditions, and oxygen consumption and carbon dioxide production will be used to calculate energy expenditure.

    Measured at lab visits 1-5 (baseline and pre- and post-interventions) from 0 to 12 weeks.

Secondary Outcomes (36)

  • Total energy expenditure (from doubly labelled water) in kcal/day

    Measured during both 7-day interventions starting at approximately week 4 and week 9.

  • Total energy expenditure ( from sum of independent components of energy expenditure) in kcal/day

    Measured during both 7-day interventions starting at approximately week 4 and week 9

  • Peripheral blood mononuclear cell (PBMC) mitochondrial respiration

    Measured pre- and post-exercise at visits 2/3 (pre- and post-intervention 1) and visits 4/5 (pre- and post-intervention 2), approximately weeks 4-12.

  • Sub-maximal exercise performance (during steady-state treadmill exercise)

    Measured at lab visits 1-5 (baseline and pre- and post-interventions) from 0 to 12 weeks.

  • Free T3 in pmol/L

    Measured at lab visits 2-5 (pre- and post-interventions) from 4 to 12 weeks.

  • +31 more secondary outcomes

Study Arms (2)

Energy deficit

EXPERIMENTAL

Diet-induced 50% energy deficit (based on estimated average total daily energy expenditure) by allocation of pre-made meals and snacks over 7-days

Dietary Supplement: Controlled energy-deficit diet

Energy surplus

EXPERIMENTAL

Diet-induced energy surplus (approximately 500-1000kcal/day) achieved by allocation of additional snacks to be consumed on top of habitual free-living diet, to avoid inadvertent energy deficit

Dietary Supplement: Habitual diet with surplus snacks

Interventions

Participants receive a prepared diet providing approximately 50% of their estimated daily energy expenditure to induce a sustained energy deficit

Also known as: Energy deficit
Energy deficit

Participants continue their normal diet with the addition of high-calorie snack items to achieve an approximate daily energy surplus

Also known as: Energy surplus
Energy surplus

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-identified endurance-trained sport participants
  • Training volume: \>7 hours per week endurance training
  • Training frequency: at least 5 days per week

You may not qualify if:

  • Diagnosis of Relative Energy Deficiency in Sport (REDs)
  • Active eating disorder (EDE-Q)
  • Active flare of a chronic disease (e.g. inflammatory bowel disease)
  • Type 1 or 2 diabetes mellitus
  • Untreated or undergoing active treatment of anaemia (any cause)
  • Current injury which precludes undertaking high volume endurance training
  • Individuals following a habitual low-carbohydrate, high-fat diet
  • Any medical diagnosis which precludes intense exercise (e.g. untreated cardiac arrhythmia)
  • Allergy or intolerance to study foods
  • Blood donation within preceding 8 weeks of study start date
  • Use of medications that affect substrate utilisation (e.g. statins, corticosteroids, thyroxine, HRT)
  • For females: current pregnancy, breastfeeding within past 6 months or post-menopausal
  • Unable to undertake a treadmill running test
  • Participation in any research study in the past 8 weeks
  • Participation in a research study within the past year involving more than one DEXA scan
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Relative Energy Deficiency in SportMotor Activity

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBehavior

Central Study Contacts

Joshua J Bakker-Dyos, BSc(Hons) MBChB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2025

First Posted

August 14, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations