- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293666
Functional Evaluation of Kefir Drink on Antifatigue and Exercise Exercise Performance-2
October 17, 2022 updated by: Chi-Chang Huang, National Taiwan Sport University
Functional Evaluation of Kefir Drink on Antifatigue and Improving Exercise Performance
Purpose: The aim of the present study was to evaluate potential beneficial effects of Kefir drink (Synbio Tech Inc., Kaohsiung City, Taiwan) on fatigue and ergogenic functions following physiological challenge.
Methods: 16 male subjects, 8 in each group, were divided into two groups according to the principle of maximal oxygen uptake, which were (1) first-stage placebo and second-stage Kefir group (hereinafter referred to as group A).
(2) The first phase of Kefeier, the second phase of the placebo group (hereinafter referred to as group B), after 4 weeks of supplementation, the performance and fatigue resistance tests were carried out in sequence, including: treadmill aerobic endurance exhaustion time, and fixation Exercise time and intensity challenge changes in blood lactate, blood urea nitrogen concentration and creatine kinase activity, as well as differences in body composition before and after supplementation.
After the first phase of the test is completed, the four weeks of emptying are performed.
And after adding the crossover sample, perform four weeks of supplementation and testing again.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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 Locations
-
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Taoyuan, Taiwan, 333
- National Taiwan Sport University
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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
16 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- >20 years old
- health
Exclusion Criteria:
- No smoking
- drinking habits
- no nutritional supplements or medications
- no food allergies
- normal liver and kidney function
- no diabetes and other chronic diseases
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kefir drink
(2) The first phase of Kefir, the second phase of the placebo group (hereinafter referred to as group B
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28 days supplementation kefir drink (prepared by inoculating pasteurized 9.2% reconstituted skim milk with powder kefir starter culture and fermented at 37 °C for 16 h.
The fermented milk was then pasteurized at 100 °C for 30 min and freeze dried.
The powder kefir starter culture used for inoculation was composed of defined lactic acid bacteria strains which contains Lactobacillus fermentum DSM 32784 (LF26), L. helveticus DSM 32787 (LH43), L. paracasei DSM 32785 (LPC12), L. rhamnosus DSM 32786 (LRH10), and Streptococcus thermophilus DSM 32788 (ST30)), 200ml/day
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Placebo Comparator: placebo
(1) first-stage placebo and second-stage Kefir group (hereinafter referred to as group A).
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Maltodextrin, same calorie as kefir, 200ml/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Biochemistry of lactate level
Time Frame: 28 days
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase.
Serum lactate (mmol/L), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
28 days
|
|
Clinical Biochemistry of ammonia level
Time Frame: 28 days
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase.
Serum ammonia (umol/L), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
28 days
|
|
Clinical Biochemistry of CK level
Time Frame: 28 days
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase.
Serum CK (U/L), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
28 days
|
|
Clinical Biochemistry of glucose level
Time Frame: 28 days
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase.
Serum glucose (mg/dL), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
28 days
|
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Exercise endurance exhaustion time
Time Frame: 28 days
|
We adopted a double-blind test in which the volunteers, based on their basal maximal oxygen consumption (VO2max).
before and after intervention, the individual basal VO2max during pretest was used as a reference to adjust the individually appropriate exercise intensity to measure exhaustive endurance (85% VO2max) and recording the running time from begin to exhaust.
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
January 27, 2019
Primary Completion (Actual)
April 18, 2019
Study Completion (Actual)
April 18, 2019
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 29, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001
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
product manufactured in and exported from the U.S.
No
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