Overtraining SyndromeNCT06466408
Effect of Vegetable and Fruit Enzyme Supplementation on Muscle Activation, Aerobic Capacity, and Blood Biochemical Parameters After High-Intensity Interval Exercise: Feasibility Study of Exercise Design With Exergaming
A study testing Supplementation Protocol, Blood Lactate Test and Training Impulse in people with Overtraining Syndrome, run by Shu-Cheng Lin at 1 site in Taiwan.
Trial summary
This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overtraining Syndrome
- What is being tested?
- Supplementation Protocol, Blood Lactate Test and Training Impulse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2024to 30 Jul 2024
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 and above
- healthy elderly participants
- regular exercise habit (3 times per week within the past year)
- Those who can move their upper and lower limbs normally
Who cannot join
- no history of upper limb skeletal muscle injury or major injury
- No heart-related diseases such as high blood pressure
- No related chronic diseases, such as diabetes
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tainan University of Technology
Tainan, 710302
SHU-CHENG LIN, PhD, +886912997187, s0975835@gmail.com
About this study
Official title: Exploring the Impact of Fruit and Vegetable Enzyme Supplementation on Aerobic Performance and Lactate Response in the Elderly Following High-Intensity Interval Exercise Combine Exergaming: Randomized Experimental Matched-Pair Study
This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.
- Conditions
- Overtraining Syndrome
- Being tested
- Supplementation Protocol, Blood Lactate Test, Training Impulse, Exergaming HIIE Test
- Medical subject headings
- Overtraining Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation ProtocolDietary supplement
After the pre-test, the enzyme group consumed 30 mL of vegetable and fruit enzymes (The contents include needle-leaf cherries, cherries, apples, cranberries, blackberries, black currants, blueberries, beets, broccoli, cabbage, carrots, Concord grapes, cranberries, elderberries, kale, oranges, peaches, papayas, parsley, pineapples, raspberries, red currants, spinach, and tomatoes, etc.)(Enzyme Village, Chiayi, Taiwan) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. The placebo group followed the same protocol but consumed malt syrup (Amazon, USA) instead until the end of the study. Participants returned to the laboratory each morning to receive the daily supplement, which was administered on-site. Following supplementation, participants reported their dinner intake to the researchers, ensuring compliance with the prescribed supplementation regimen.
Blood Lactate TestDiagnostic test
The blood lactate was measured at five time points: before exercise, after the fourth and eighth bouts of exercise, and at 5 and 10 minutes after exercise. The blood lactate were analyzed using a Biosen Cline blood analysis system (EKF-diagnostic, Germany). Capillary blood samples of 10 μL were collected and added to red blood cell lysis reagent and stored at low temperature until analyzed. Prior to analysis, instrument standardization and test calibration were performed, and the coefficient of variation was determined to be ≤1.5%. The detection range for blood lactate was 0.5-40 mM
Training ImpulseDiagnostic test
In this study, the exercise load was represented by the TRIMP [32], which is calculated as the product of exercise intensity and duration. To accommodate the convenience of the experiment, two different TRIMP calculation methods were used, including % HRmax (objective) and RPE (subjective). At the end of each exercise bout (8 bouts in total) and during the recovery period before the next bout (7 bouts in total), participants were asked to report their RPE, and their heart rate was recorded. This process was repeated 8 times.
Exergaming HIIE TestDiagnostic test
The sensor system utilized two Nintendo controllers: one mounted on the exercise ring and the other secured to the participant's thigh to enhance gameplay interaction. Through the Ring-Con, participants engaged in diverse physical activities such as weightlifting, yoga, and aerobic exercises. The fitness ring sensor accurately captures and integrates players' movements into the game. The gameplay involves unlocking levels and engaging in fitness challenges that are achieved through actual physical activities. It offers a wide range of exercise routines targeting various muscle groups and provides engaging gaming challenges. The exercise protocol included eight sets of 20-second high-effort exercises, interspersed with 30-second rest intervals, totaling 370 seconds of active exercise time. Specifically, the fitness game mode used was the Adventure Mode in 'Ring Fit Adventure,' comprising exercises targeting the pectoralis major, latissimus dorsi, deltoids, and quadriceps muscles.
| Study group | Role | What they receive |
|---|---|---|
| enzyme group | Experimental | enzyme group consumed 30 mL of vegetable and fruit enzymes (The contents include needle-leaf cherries, cherries, apples, cranberries, blackberries, black currants, blueberries, beets, broccoli, cabbage, carrots, Concord grapes, cranberries, elderberries, kale, oranges, peaches, papayas, parsley, pineapples, raspberries, red currants, spinach, and tomatoes, etc.)(Enzyme Village, Chiayi, Taiwan) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. Receives: Dietary Supplement: Supplementation Protocol; Diagnostic Test: Blood Lactate Test; Diagnostic Test: Training Impulse; Diagnostic Test: Exergaming HIIE Test |
| placebo group | Placebo comparator | The placebo group followed the same protocol but consumed malt syrup (Amazon, USA) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. Receives: Dietary Supplement: Supplementation Protocol; Diagnostic Test: Blood Lactate Test; Diagnostic Test: Training Impulse; Diagnostic Test: Exergaming HIIE Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate
Measure lactate level with fingertip blood test in Exergaming HIIE
Measured: pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.
Heart rate (bpm)
Use a heart rate monitor to record heart rate in Exergaming HIIE
Measured: Collect the heart rate at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Borg 0-10 score rating of perceived exertion (RPE)
Use Borg 0-10 score RPE to record RPE in Exergaming HIIE
Measured: Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Secondary outcomes (1)
Training Impulse
Calculate the subjective and objective training Impulse (arbitrary unit, AU) based on the heart rate and RPE.
Measured: During Exergaming HIIE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overtraining SyndromeStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- groups -enzyme and -placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Cheng Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Cheng Lin, Tainan University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466408
- Sponsor's protocol ID
- NCKU HREC-E-112-419-2
- Status last verified
- Jun 2024
- First submitted
- 18 May 2024
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Fruit and Vegetable Enzyme Supplementation on Aerobic Performance and Lactate Response in the Elderly Following High-Intensity Interval Exercise Combine Exergaming: Randomized Experimental Matched-Pair Study
- ClinicalTrials.gov ID
- NCT06466408
- Acronym / sponsor ID
- NCKU HREC-E-112-419-2
- Conditions
- Overtraining Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shu-Cheng LinUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 20 Jun 2024 (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.
This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- groups -enzyme and -placebo
| Arm | Type | Receives |
|---|---|---|
| enzyme group | Experimental | Dietary Supplement: Supplementation Protocol, Diagnostic Test: Blood Lactate Test, Diagnostic Test: Training Impulse, Diagnostic Test: Exergaming HIIE Testenzyme group consumed 30 mL of vegetable and fruit enzymes (The contents include needle-leaf cherries, cherries, apples, cranberries, blackberries, black currants, blueberries, beets, broccoli, cabbage, carrots, Concord grapes, cranberries, elderberries, kale, oranges, peaches, papayas, parsley, pineapples, raspberries, red currants, spinach, and tomatoes, etc.)(Enzyme Village, Chiayi, Taiwan) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. |
| placebo group | Placebo comparator | Dietary Supplement: Supplementation Protocol, Diagnostic Test: Blood Lactate Test, Diagnostic Test: Training Impulse, Diagnostic Test: Exergaming HIIE TestThe placebo group followed the same protocol but consumed malt syrup (Amazon, USA) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 and above
- healthy elderly participants
- regular exercise habit (3 times per week within the past year)
- Those who can move their upper and lower limbs normally
Key exclusion criteria (3 listed)
- no history of upper limb skeletal muscle injury or major injury
- No heart-related diseases such as high blood pressure
- No related chronic diseases, such as diabetes
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 |
|---|---|---|
| Supplementation ProtocolAfter the pre-test, the enzyme group consumed 30 mL of vegetable and fruit enzymes (The contents include needle-leaf cherries, cherries, apples, cranberries, blackberries, black currants, blueberries, beets, broccoli, cabbage, carrots, Concord grapes, cranberries, elderberries, kale, oranges, peaches, papayas, parsley, pineapples, raspberries, red currants, spinach, and tomatoes, etc.)(Enzyme Village, Chiayi, Taiwan) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. The placebo group followed the same protocol but consumed malt syrup (Amazon, USA) instead until the end of the study. Participants returned to the laboratory each morning to receive the daily supplement, which was administered on-site. Following supplementation, participants reported their dinner intake to the researchers, ensuring compliance with the prescribed supplementation regimen. | Dietary supplement | enzyme group, placebo group |
| Blood Lactate TestThe blood lactate was measured at five time points: before exercise, after the fourth and eighth bouts of exercise, and at 5 and 10 minutes after exercise. The blood lactate were analyzed using a Biosen Cline blood analysis system (EKF-diagnostic, Germany). Capillary blood samples of 10 μL were collected and added to red blood cell lysis reagent and stored at low temperature until analyzed. Prior to analysis, instrument standardization and test calibration were performed, and the coefficient of variation was determined to be ≤1.5%. The detection range for blood lactate was 0.5-40 mM | Diagnostic test | enzyme group, placebo group |
| Training ImpulseIn this study, the exercise load was represented by the TRIMP [32], which is calculated as the product of exercise intensity and duration. To accommodate the convenience of the experiment, two different TRIMP calculation methods were used, including % HRmax (objective) and RPE (subjective). At the end of each exercise bout (8 bouts in total) and during the recovery period before the next bout (7 bouts in total), participants were asked to report their RPE, and their heart rate was recorded. This process was repeated 8 times. | Diagnostic test | enzyme group, placebo group |
| Exergaming HIIE TestThe sensor system utilized two Nintendo controllers: one mounted on the exercise ring and the other secured to the participant's thigh to enhance gameplay interaction. Through the Ring-Con, participants engaged in diverse physical activities such as weightlifting, yoga, and aerobic exercises. The fitness ring sensor accurately captures and integrates players' movements into the game. The gameplay involves unlocking levels and engaging in fitness challenges that are achieved through actual physical activities. It offers a wide range of exercise routines targeting various muscle groups and provides engaging gaming challenges. The exercise protocol included eight sets of 20-second high-effort exercises, interspersed with 30-second rest intervals, totaling 370 seconds of active exercise time. Specifically, the fitness game mode used was the Adventure Mode in 'Ring Fit Adventure,' comprising exercises targeting the pectoralis major, latissimus dorsi, deltoids, and quadriceps muscles. | Diagnostic test | enzyme group, placebo group |
Primary outcome
Lactate
Time frame: pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.
Measure lactate level with fingertip blood test in Exergaming HIIE
Heart rate (bpm)
Time frame: Collect the heart rate at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Use a heart rate monitor to record heart rate in Exergaming HIIE
Borg 0-10 score rating of perceived exertion (RPE)
Time frame: Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Use Borg 0-10 score RPE to record RPE in Exergaming HIIE
1 secondary outcome
Training Impulse
Time frame: During Exergaming HIIE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation Protocol, Blood Lactate Test and Training Impulse in people with Overtraining Syndrome, run by Shu-Cheng Lin 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHU-CHENG LIN, PhD (+886912997187, s0975835@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate (time frame: pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.). 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 20 Jun 2024.