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临床试验/NCT06208761
NCT06208761已完成2 期

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

Burapha University1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2023年5月9日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
141
试验地点
1
主要终点
Concentration of interferon-gamma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Placebo capsule supplementation

Placebo Comparator

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.

干预措施: Triphala capsule supplementation and high-intensity interval training (Other)

Triphala capsule supplementation

Experimental

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.

干预措施: Triphala capsule supplementation and high-intensity interval training (Other)

High-intensity interval training

Experimental

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.

干预措施: Triphala capsule supplementation and high-intensity interval training (Other)

Triphala capsule supplementation and high-intensity interval training

Experimental

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.

干预措施: Triphala capsule supplementation and high-intensity interval training (Other)

结局指标

主要结局

Concentration of interferon-gamma

时间窗: Before and after 8 weeks

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

Concentration of blood protein carbonyl

时间窗: Before and after 8 weeks

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

Concentration of blood malondialdehyde

时间窗: Before and after 8 weeks

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

Concentration of tumor necrosis factor-alpha

时间窗: Before and after 8 weeks

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

次要结局

  • Concentration of blood alanine aminotransferase enzyme(Before and after 8 weeks)
  • Concentration of blood creatinine(Before and after 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piyapong Prasertsri

Associate Professor Dr.

Burapha University

研究点 (1)

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