Triphala Supplementation and High-intensity Interval Exercise and Immune System Function and Oxidative Stress

NCT06208761 | Completed Phase 2 DMC

• 1 other identifier: IRB1-050/2566
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triphala Capsule Supplementation; High-intensity Interval Training

Outcome Measures

Primary Outcomes (4)

• Concentration of interferon-gamma

  Concentration of interferon-gamma was measured in serum in pg (picogram)/mL unit

  Before and after 8 weeks

• Concentration of tumor necrosis factor-alpha

  Concentration of tumor necrosis factor-alpha was measured in serum in pg (picogram)/mL unit

  Before and after 8 weeks

• Concentration of blood malondialdehyde

  Concentration of malondialdehyde was measured in plasma in uM (micromolar) unit

  Before and after 8 weeks

• Concentration of blood protein carbonyl

  Concentration of protein carbonyl was measured in plasma in nmol/mg protein unit

  Before and after 8 weeks

Secondary Outcomes (2)

• Concentration of blood alanine aminotransferase enzyme

  Before and after 8 weeks

• Concentration of blood creatinine

  Before and after 8 weeks

Study Arms (4)

Placebo capsule supplementation

PLACEBO COMPARATOR

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

EXPERIMENTAL

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

High-intensity interval training

EXPERIMENTAL

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 and high-intensity interval training

EXPERIMENTAL

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

Interventions

Triphala capsule supplementation and high-intensity interval training OTHER

Triphala capsule supplementation is categorized in dietary supplement but and high-intensity interval training is included as other

High-intensity interval training; Placebo capsule supplementation; Triphala capsule supplementation; Triphala capsule supplementation and high-intensity interval training

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Faculty of Allied Health Sciences, Burapha University

Mueang, Changwat Chon Buri, 20131, Thailand

Location

MeSH Terms

Interventions

triphala; Dietary Supplements; High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 17, 2024
• Study Start: May 9, 2023
• Primary Completion: October 22, 2023
• Study Completion: November 6, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)