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

Phase 2
Completed
Conditions
Triphala Capsule Supplementation
High-intensity Interval Training
Interventions
Other: Triphala capsule supplementation and high-intensity interval training
Registration Number
NCT06208761
Lead Sponsor
Burapha University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
141
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo capsule supplementationTriphala capsule supplementation and high-intensity interval trainingParticipants 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 supplementationTriphala capsule supplementation and high-intensity interval trainingParticipants 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.
High-intensity interval trainingTriphala capsule supplementation and high-intensity interval trainingParticipants 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 and high-intensity interval trainingTriphala capsule supplementation and high-intensity interval trainingParticipants 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.
Primary Outcome Measures
NameTimeMethod
Concentration of tumor necrosis factor-alphaBefore and after 8 weeks

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

Concentration of blood protein carbonylBefore and after 8 weeks

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

Concentration of interferon-gammaBefore and after 8 weeks

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

Concentration of blood malondialdehydeBefore and after 8 weeks

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

Secondary Outcome Measures
NameTimeMethod
Concentration of blood creatinineBefore and after 8 weeks

Concentration of creatinine was measured in serum in mg/dL unit

Concentration of blood alanine aminotransferase enzymeBefore and after 8 weeks

Concentration of alanine aminotransferase enzyme was measured in serum in U/L unit

Trial Locations

Locations (1)

Faculty of Allied Health Sciences, Burapha University

🇹🇭

Mueang, ChonBuri, Thailand

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