The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

The study is labelled as a single-blinded study because the investigators are blinded to the group allocation (the group allocation and diet handling is managed by a researcher not involved in other aspects of the data collection or processing). The participants are not informed about their allocated condition, however, it is conceivably possible for them to recognize this based on the food provided. However, the direction of the hypothesis will not be evident to the participants. Moreover, we include questionnaires before the post-tests related to their perceived diet allocation and their perception of the effect of the diet on the test assessments.

Study Groups

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Low-carbohydrate calorie-restriction

Minimum of 3 g carbohydrate/kg body weight/day and a \~1000 kcal calorie restriction

Group Type ACTIVE_COMPARATOR

Calorie-restriction with low carbohydrate

Intervention Type OTHER

Calorie-restriction and low carbohydrate availability

Moderate-carbohydrate calorie-restriction

Maximum of 1 g carbohydrate/kg body weight/day and a \~1000 kcal calorie restriction

Group Type EXPERIMENTAL

Calorie-restriction with moderate carbohydrate

Intervention Type OTHER

Calorie-restriction and moderate carbohydrate availability

Interventions

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Calorie-restriction with low carbohydrate

Calorie-restriction and low carbohydrate availability

Intervention Type OTHER

Calorie-restriction with moderate carbohydrate

Calorie-restriction and moderate carbohydrate availability

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes