- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466408
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
June 13, 2024 updated by: Shu-Cheng Lin
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: SHU-CHENG LIN, PhD
- Phone Number: +886912997187
- Email: s0975835@gmail.com
Study Locations
-
-
-
Tainan City, Taiwan, 710302
- Recruiting
- Tainan University of Technology
-
Contact:
- SHU-CHENG LIN, PhD
- Phone Number: +886912997187
- Email: s0975835@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: enzyme group
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.
|
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.
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
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.
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.
|
|
Placebo Comparator: placebo group
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.
|
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.
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
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
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
|
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)
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
|
Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training Impulse
Time Frame: During Exergaming HIIE
|
Calculate the subjective and objective training Impulse (arbitrary unit, AU) based on the heart rate and RPE.
|
During Exergaming HIIE
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 25, 2024
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
May 18, 2024
First Submitted That Met QC Criteria
June 13, 2024
First Posted (Actual)
June 20, 2024
Study Record Updates
Last Update Posted (Actual)
June 20, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- NCKU HREC-E-112-419-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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