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NCT Number: NCT06381908

The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity

The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Section for Sport Science, Department of Public Health, Aarhus University

Aarhus C, 8000, Denmark

About this study

Overweight (BMI 25-30), but healthy premenopausal women aged 20-35 years (n=40) will be included in the trial, which is structured as a randomized, parallel group design where participants are randomized to either consume a hypocaloric diet (-1000 kcal) with concurrent carbohydrate restriction (low carbohydrate, L-CHO, n=20) or a similar hypocaloric diet with moderate carbohydrate availability (moderate carbohydrate, M-CHO, n=20). The trial will be single-blinded since it might be transparent to the participants which diet they are consuming, whereas the test personnel collecting and processing test results will be blinded to diet allocation. Diet handling will be managed by specific individuals in the research group who do not partake in executing the physical capacity tests. Additionally, the direction of the trial's primary hypothesis will not be disclosed to the participants to avoid creating preconceived expectations about the effects.

After an initial screening interview and two familiarization visits, participants will complete the intervention period consisting of 10 days with the allocated diet manipulation with preceding and subsequent test days with a series of tests. The tests before and after each test period include measurements of the participants' physical capacity level and energy metabolism in the laboratory as well as blood and muscle sampling. In addition, resting metabolism and body composition will be measured. During each test period, participants' habitual activity level will be monitored with an accelerometer attached to the wrist (Axivity). There will also be monitoring of the activity level with an accelerometer in a 7-day cycle before the start of the trial as a baseline measurement.

Similarly, a glucose monitor will be placed on the upper arm for continuous glucose readings via a Freestyle Libre2 sensor during the trial period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20-35
  • BMI: 25-30

Exclusion criteria

  • Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)
  • Injuries / pain in the lower body, which prevents participation in intense cycling
  • Medication consumption that may affect primary outcome measures.
  • Smoking
  • Pregnancy
  • Systematic physical activity more than 2 hours per week

Treatment and study plan

Calorie-restriction with low carbohydrate

Other

Calorie-restriction and low carbohydrate availability

Calorie-restriction with moderate carbohydrate

Other

Calorie-restriction and moderate carbohydrate availability

Primary outcomes

  1. Time to exhaustion

    Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)

    Time to exhaustion at 85% VO2max

  2. Sprint performance

    Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)

    Peak and mean 15-s sprint performance

  3. Exercise tolerance

    Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)

    Ratings of perceived exertion (Borg scale) during standardized-intensity exercise from 6 (lowest exertion) to 20 (highest exertion)

  4. Muscle glycogen levels

    Time frame: Pre and post (day 11 of the intervention)

    Muscle glycogen levels obtained from biopsy sample

Secondary outcomes

  1. Physical activity level

    Time frame: During the intervention (days 1 to 11 of the intervention)

    Measured with accelerometer during the intervention

  2. Maximal fat oxidation capacity

    Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)

    Maximal fat oxidation measured in the laboratory

  3. Muscle metabolic enzyme activity

    Time frame: Pre and post (day 11 of the intervention)

    Activity of key enzymes involved in carbohydrate and fat metabolism

  4. Blood lipid profile

    Time frame: Pre and post (day 11 of the intervention)

    High-density lipoproteins, low-density lipoproteins, very-low-density lipoproteins, cholesterol, free fatty acids and triglycerides

  5. Continuous glucose levels

    Time frame: 14 days from the day before the intervention, throughout the intervention (days 1 to 11) and 2 days after the intervention (follow-up)

    Glucose levels measured continuously across the trial + during exercise tests

  6. Fasting blood glucose and insulin

    Time frame: Pre and post (day 11 of the intervention)

    Insulin sensitivity (Homa 2 IR)

  7. Long-term glycemic control (HbAc1)

    Time frame: Pre and post (day 11 of the intervention)

    Measured from fasting blood

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • University Ghent
  • University of Southern Denmark

Registry information

Official study title

The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity and Health in Overweight Women

Acronym: CHO-EX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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