Diet, ReducingNCT05017259
Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes
A study testing calorie restriction diet in people with Diet, Reducing, run by Chin Hsu at 1 site in Taiwan.
Trial summary
Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. Read more about this study
- Who is it for?
- Ages 20 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Reducing
- What is being tested?
- calorie restriction diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2019to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have at least 6 years of Taekwondo training experience
- Must have participated in domestic or international competitions
Who cannot join
- Smoking
- Cardiovascular disease
- Diabetes
- Hypertension
- Any medication in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Metabolomic Exploration of Low-carbohydrate and Calorie Restriction Diet on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Taekwondo Athletes
Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. The purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.
Read the detailed description
This study used a randomized cross-over design. Each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.
- Conditions
- Diet, Reducing
- Being tested
- calorie restriction diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calorie restriction dietDietary supplement
The 7-day low-calorie diet contained 15.8 ± 0.4 kcal/kg/d in both trials, divided into three meals a day.
| Study group | Role | What they receive |
|---|---|---|
| low carbohydrate trial | Experimental | The energy distribution was carbohydrate 10%, protein 40-50%, fat 40-50% in the LC trial. Receives: Dietary Supplement: calorie restriction diet |
| high carbohydrate trial | Active comparator | The energy distribution was carbohydrate 60-65%, protein 30-40%, fat 5-10% in the HC trial. Receives: Dietary Supplement: calorie restriction diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kilograms assessed by air-displacement plethysmography (Bod Pod)
The body weight (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
Measured: 1 min
Body fat mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
The body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
Measured: 1 min
Lean body mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
The lean body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
Measured: 1 min
Secondary outcomes (1)
Taekwondo-specific reaction time in seconds assessed by Electromyography (EMG) signals
The reaction time (sec) was measured before and after weight loss to assess the difference in exercise performance. The participants were asked to make the fist on the left hand as soon as they see a light signal, then start the taekwondo-specific movement. The reaction time was calculated as the time from the beginning of the light signal to the start of electromyography (EMG) signal of the left thenar muscles. The movement was performed 5 times. The average reaction time was used to arrive at one reported value.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start17 Aug 2019
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, ReducingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chin Hsu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chin Hsu, National Taiwan Sport University
- Investigators
- Chin Hsu, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017259
- Sponsor's protocol ID
- MOST 108-2410-H-028-005
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolomic Exploration of Low-carbohydrate and Calorie Restriction Diet on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Taekwondo Athletes
- ClinicalTrials.gov ID
- NCT05017259
- Acronym / sponsor ID
- MOST 108-2410-H-028-005
- Conditions
- Diet, Reducing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chin HsuUniversity, hospital or other
- Study start
- 17 Aug 2019 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. The purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.
Detailed description
This study used a randomized cross-over design. Each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low carbohydrate trial | Experimental | Dietary Supplement: calorie restriction dietThe energy distribution was carbohydrate 10%, protein 40-50%, fat 40-50% in the LC trial. |
| high carbohydrate trial | Active comparator | Dietary Supplement: calorie restriction dietThe energy distribution was carbohydrate 60-65%, protein 30-40%, fat 5-10% in the HC trial. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must have at least 6 years of Taekwondo training experience
- Must have participated in domestic or international competitions
Key exclusion criteria (5 listed)
- Smoking
- Cardiovascular disease
- Diabetes
- Hypertension
- Any medication in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calorie restriction dietThe 7-day low-calorie diet contained 15.8 ± 0.4 kcal/kg/d in both trials, divided into three meals a day. | Dietary supplement | high carbohydrate trial, low carbohydrate trial |
Primary outcome
Body weight in kilograms assessed by air-displacement plethysmography (Bod Pod)
Time frame: 1 min
The body weight (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
Body fat mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
Time frame: 1 min
The body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
Lean body mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
Time frame: 1 min
The lean body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.
1 secondary outcome
Taekwondo-specific reaction time in seconds assessed by Electromyography (EMG) signals
Time frame: 1 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Hsu principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorie restriction diet in people with Diet, Reducing, run by Chin Hsu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight in kilograms assessed by air-displacement plethysmography (Bod Pod) (time frame: 1 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.