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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

SHU-CHENG LIN, PhD contact

+886912997187

s0975835@gmail.com

Taiwan1 site, 1 recruiting
  • Tainan University of Technology

    Tainan, 710302

    SHU-CHENG LIN, PhD, +886912997187, s0975835@gmail.com

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT06466408
Study groupRoleWhat they receive
enzyme groupExperimentalenzyme 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 groupPlacebo comparatorThe 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.

  1. 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.

  2. 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

  3. 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)
  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.

  1. First posted20 Jun 2024
  2. Study start25 Jun 2024 (estimated)
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Resources

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)
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

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.

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