NCT06466408

Brief 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. 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.

Trial Health

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Trial Health Score

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Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

May 18, 2024

Last Update Submit

June 13, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Lactate

    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)

    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)

    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 Outcomes (1)

  • Training Impulse

    During Exergaming HIIE

Study Arms (2)

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.

Dietary Supplement: Supplementation ProtocolDiagnostic Test: Blood Lactate TestDiagnostic Test: Training ImpulseDiagnostic 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.

Dietary Supplement: Supplementation ProtocolDiagnostic Test: Blood Lactate TestDiagnostic Test: Training ImpulseDiagnostic Test: Exergaming HIIE Test

Interventions

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.

enzyme groupplacebo group
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

enzyme groupplacebo group
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.

enzyme groupplacebo group
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.

enzyme groupplacebo group

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tainan University of Technology

Tainan, 710302, Taiwan

RECRUITING

MeSH Terms

Conditions

Overtraining Syndrome

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

SHU-CHENG LIN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
groups -enzyme and -placebo single blind
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: groups -enzyme and -placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2024

First Posted

June 20, 2024

Study Start

June 25, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations