Clinical trial NCT06208761: Triphala Supplementation and High-intensity Interval Exercise and Immune System Function and Oxidative Stress
Official title: Effects of Triphala Supplementation and High-intensity Interval Exercise on Immune System Function and Oxidative Stress in People With Long COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triphala Capsule Supplementation
High-intensity Interval Training
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of interferon-gamma
timeFrame: Before and after 8 weeks
measure: Concentration of tumor necrosis factor-alpha
timeFrame: Before and after 8 weeks
measure: Concentration of blood malondialdehyde
timeFrame: Before and after 8 weeks
measure: Concentration of blood protein carbonyl
timeFrame: Before and after 8 weeks
Secondary outcomes:
measure: Concentration of blood alanine aminotransferase enzyme
timeFrame: Before and after 8 weeks
measure: Concentration of blood creatinine
timeFrame: Before and after 8 weeks
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: Faculty of Allied Health Sciences, Burapha University
state: ChonBuri
Study officials:
References: