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

High-intensity Interval Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06208761
• Other study ID #: IRB1-050/2566
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2023
• Est. completion date: November 6, 2023

Study information

• Verified date: January 2024
• Source: Burapha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: November 6, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• High-intensity Interval Training

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Allied Health Sciences, Burapha University	Mueang	ChonBuri

Sponsors (1)

Lead Sponsor	Collaborator
Burapha University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of interferon-gamma	Concentration of interferon-gamma was measured in serum in pg (picogram)/mL unit	Before and after 8 weeks
Primary	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
Primary	Concentration of blood malondialdehyde	Concentration of malondialdehyde was measured in plasma in uM (micromolar) unit	Before and after 8 weeks
Primary	Concentration of blood protein carbonyl	Concentration of protein carbonyl was measured in plasma in nmol/mg protein unit	Before and after 8 weeks
Secondary	Concentration of blood alanine aminotransferase enzyme	Concentration of alanine aminotransferase enzyme was measured in serum in U/L unit	Before and after 8 weeks
Secondary	Concentration of blood creatinine	Concentration of creatinine was measured in serum in mg/dL unit	Before and after 8 weeks