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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Triphala capsule supplementation and high-intensity interval training
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.
Other: Triphala capsule supplementation and high-intensity interval training
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.
Other: Triphala capsule supplementation and high-intensity interval training
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.
Other: Triphala capsule supplementation and high-intensity interval training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Burapha University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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