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

Burapha University

Status and phase: Completed; Phase 2

Conditions: High-intensity Interval Training; Triphala Capsule Supplementation

Treatments: Other: Triphala capsule supplementation and high-intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT06208761

IRB1-050/2566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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141 participants in 4 patient groups, including a placebo group

Placebo capsule supplementation

Placebo Comparator group

Description:

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.

Treatment:

Other: Triphala capsule supplementation and high-intensity interval training

Triphala capsule supplementation

Experimental group

Description:

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.

Treatment:

Other: Triphala capsule supplementation and high-intensity interval training

High-intensity interval training

Experimental group

Description:

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.

Treatment:

Other: Triphala capsule supplementation and high-intensity interval training

Triphala capsule supplementation and high-intensity interval training

Experimental group

Description:

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.

Treatment:

Other: Triphala capsule supplementation and high-intensity interval training