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Completed

NCT Number: NCT06208761

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Allied Health Sciences, Burapha University

Mueang, Changwat Chon Buri, 20131, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Concentration of interferon-gamma

    Time frame: Before and after 8 weeks

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

  2. 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

  3. Concentration of blood malondialdehyde

    Time frame: Before and after 8 weeks

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

  4. 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

Secondary outcomes

  1. 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

  2. Concentration of blood creatinine

    Time frame: Before and after 8 weeks

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

Sponsors and collaborators

Lead sponsor

Burapha University

Other

Registry information

Official study title

Effects of Triphala Supplementation and High-intensity Interval Exercise on Immune System Function and Oxidative Stress in People With Long COVID

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2024
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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