- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06208761
Triphala Supplementation and High-intensity Interval Exercise and Immune System Function and Oxidative Stress
January 5, 2024 updated by: Piyapong Prasertsri, Burapha University
Effects of Triphala Supplementation and High-intensity Interval Exercise on Immune System Function and Oxidative Stress in People With Long COVID
One hundred and forty-one male and female participants aged 18-59 years were randomly divided into 4 groups: 1) control group: neither received exercise program nor supplement but received placebo capsule for 8 weeks 2) experiment-1: received Triphala capsule at 1,000 mg/day, before breakfast for 500 mg and before dinner for 500 mg, for consecutive 5 days/week for 8 weeks 3) experiment-2: received leg cycling exercise program in the form of high-intensity interval training (HIIT) for 28 min/day, 3 days/week for 8 weeks and 4) experiment-3: received both Triphala capsule and HIIT in the similar extent to the experiment-1 and experiment-2 groups for 8 weeks.
Immune system function and oxidative stress including blood interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-alpha), malondialdehyde (MDA), and protein carbonyls levels were analyzed.
In addition, blood alanine aminotransferase (ALT) enzyme and creatinine levels were also analyzed for determining liver and kidney toxicity, particularly in the Triphala supplementation and combined Triphala supplementation and HIIT groups.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study aimed to investigate and compare immune system function and oxidative stress before and after supplementation with Triphala and high-intensity interval training in individuals with post COVID-19.
One hundred and forty-one male and female participants aged 18-59 years were randomly divided into 4 groups: 1) control group: neither received exercise program nor supplement but received placebo capsule for 8 weeks 2) experiment-1: received Triphala capsule at 1,000 mg/day, before breakfast for 500 mg and before dinner for 500 mg, for consecutive 5 days/week for 8 weeks 3) experiment-2: received leg cycling exercise program in the form of high-intensity interval training (HIIT) for 28 min/day, 3 days/week for 8 weeks and 4) experiment-3: received both Triphala capsule and HIIT in the similar extent to the experiment-1 and experiment-2 groups for 8 weeks.
Immune system function and oxidative stress including blood interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-alpha), malondialdehyde (MDA), and protein carbonyls levels were analyzed.
In addition, blood alanine aminotransferase (ALT) enzyme and creatinine levels were also analyzed for determining liver and kidney toxicity, particularly in the Triphala supplementation and combined Triphala supplementation and HIIT groups.
Results showed that levels of IFN-gamma, TNF-alpha, MDA, and protein carbonyls before 8-week program were not different among 4 groups.
After the program the levels of IFN-gamma, TNF-alpha, MDA, and protein carbonyls were significantly decreased in the Triphala supplementation, HIIT, and combined Triphala supplementation and HIIT groups (all p < 0.05).
However, there were no significant differences between groups.
Besides, levels of ALT enzyme and creatinine were not different among the 4 groups both before and after the 8-week program.
There were also no significant differences between groups.
This study concluded that in individuals with post COVID-19, Triphala supplementation at 1,000 mg/day, 5 days/week for consecutive 8 weeks can improve immune system function and alleviate oxidative stress.
These outcomes are similar to those of HIIT and combined Triphala supplementation and HIIT interventions.
However, prolonged investigation periods may help observing differences between interventions.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Phase 2
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
-
-
ChonBuri
-
Mueang, ChonBuri, Thailand, 20131
- Faculty of Allied Health Sciences, Burapha University
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Passed COVID-19 infection for at least 4 weeks with a symptom of long COVID including regular fatigue, headache, inability to concentrate, hair loss, and dyspnea (the symptom was exacerbated by exercise or concentration)
- Aged between 18 to 59 years
- Normal body mass index (BMI 18.5 to 24.9 kg/m2)
Exclusion Criteria:
- Regular exerciser (>2 times per week or >150 min per week)
- Regular intake of dietary supplements, i.e., vitamins, antioxidants, herbs
- Regular smokers or alcohol drinkers (>2 times per week)
- Food allergy, especially herbs i.e., emblic myrobalan, chebulic myrobalan, beleric myrobalan
- Hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer
- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo capsule supplementation
Participants were randomized to receive an arm.
In this arm, participants consumed placebo capsule for 2 capsules daily consisting of 1 capsule (500 mg) before breakfast and 1 capsule (500 mg) before dinner, 5 days/week - separated by a couple of days, for 8 weeks.
Consumption was taken at participants' dwelling.
|
Triphala capsule supplementation is categorized in dietary supplement but and high-intensity interval training is included as other
|
Experimental: Triphala capsule supplementation
Participants were randomized to receive an arm.
In this arm, participants consumed Triphala capsule for 2 capsules daily consisting of 1 capsule (500 mg) before breakfast and 1 capsule (500 mg) before dinner, 5 days/week - separated by a couple of days, for 8 weeks.
Consumption was taken at participants' dwelling.
|
Triphala capsule supplementation is categorized in dietary supplement but and high-intensity interval training is included as other
|
Experimental: High-intensity interval training
Participants were randomized to receive an arm.
In this arm, participants received leg cycling exercise program in the form of high-intensity interval training for 28 min/day, 3 days/week for 8 weeks.
Exercise training was performed at Burapha University.
|
Triphala capsule supplementation is categorized in dietary supplement but and high-intensity interval training is included as other
|
Experimental: Triphala capsule supplementation and high-intensity interval training
Participants were randomized to receive an arm.
In this arm, participants received both Triphala capsule and high-intensity interval training in the similar extent to the Triphala capsule supplementation and high-intensity interval training arms.
Consumption was taken at participants' dwelling and exercise training was performed at Burapha University.
|
Triphala capsule supplementation is categorized in dietary supplement but and high-intensity interval training is included as other
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of interferon-gamma
Time Frame: Before and after 8 weeks
|
Concentration of interferon-gamma was measured in serum in pg (picogram)/mL unit
|
Before and after 8 weeks
|
Concentration of tumor necrosis factor-alpha
Time Frame: Before and after 8 weeks
|
Concentration of tumor necrosis factor-alpha was measured in serum in pg (picogram)/mL unit
|
Before and after 8 weeks
|
Concentration of blood malondialdehyde
Time Frame: Before and after 8 weeks
|
Concentration of malondialdehyde was measured in plasma in uM (micromolar) unit
|
Before and after 8 weeks
|
Concentration of blood protein carbonyl
Time Frame: Before and after 8 weeks
|
Concentration of protein carbonyl was measured in plasma in nmol/mg protein unit
|
Before and after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of blood alanine aminotransferase enzyme
Time Frame: Before and after 8 weeks
|
Concentration of alanine aminotransferase enzyme was measured in serum in U/L unit
|
Before and after 8 weeks
|
Concentration of blood creatinine
Time Frame: Before and after 8 weeks
|
Concentration of creatinine was measured in serum in mg/dL unit
|
Before and after 8 weeks
|
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 (Actual)
May 9, 2023
Primary Completion (Actual)
October 22, 2023
Study Completion (Actual)
November 6, 2023
Study Registration Dates
First Submitted
December 21, 2023
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB1-050/2566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers
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.
Clinical Trials on High-intensity Interval Training
-
University of MiamiCompletedResistance Training | High-Intensity Interval TrainingUnited States
-
University of Central LancashireUniversity of HullCompletedHigh Intensity Interval TrainingUnited Kingdom
-
Riphah International UniversityRecruiting
-
University of NottinghamCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityCompleted
-
University of BathCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityLiverpool John Moores UniversityCompletedHigh-intensity Interval Training
-
University of North Carolina, Chapel HillNational Institute for Occupational Safety and Health (NIOSH/CDC)Enrolling by invitationHigh Intensity Interval Training | FirefighterUnited States
-
Ankara UniversityCompletedHigh Intensity Interval Training | CreatineTurkey
-
Superior UniversityEnrolling by invitationHigh Intensity Interval Training | Aerobic ExercisePakistan
Clinical Trials on Triphala capsule supplementation and high-intensity interval training
-
University of MichiganCompletedGlucose IntoleranceUnited States
-
Universidad SurcolombianaMaciste Macias; Gilberto AstaizaRecruiting
-
Kuopio Research Institute of Exercise MedicineKuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, FinlandTerminatedUnstable Angina Pectoris | Acute Myocardial Infarction | Recurrent Myocardial InfarctionFinland
-
Cairo UniversityKasr El Aini HospitalCompletedDiabetes Mellitus, Type 2Egypt
-
Universidad Santo TomasCompletedMetabolic DiseasesColombia
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
Hunter College of City University of New YorkRecruiting
-
Université de SherbrookeRecruiting
-
Riphah International UniversityCompleted