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临床试验/CTRI/2024/04/065114
CTRI/2024/04/065114尚未招募1 期

Autonomic variations changes in body composition and attention at different stages during 7 days of Therapeutic Naturopathic Fasting in healthy students an experimental study

Swami vivekananda yoga anusandhana kendra1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Heart Rate Variability HRV

研究概览

简要总结

Fasting or abstinence from food or drink or both are done for health, ritualistic, religious purposes. The abstention may be complete or partial, lengthy, of short duration, or intermittent. Fasting has been used therapeutically since at least the 5th century BCE, when Greek physician Hippocrates recommended abstinence from food or drink for patients who exhibited certain symptoms of illness. Fasting was used as a treatment and as a form of disease prevention.Periods of fasting with restriction of solid food intake are practiced worldwide, mostly based on traditional, cultural or religious reasons. There are no studies which includes fair number of subjects & which explains effects about the actual therapeutic naturopathic fasting. Hence this study is done to identify the biochemical changes during therapeutic naturopathic fasting.

Aim is to identify the effect of therapeutic naturopathic fasting on Autonomic variations, body composition and attention in healthy volunteers.

Objectives are to identify the effect of therapeutic naturopathic fastingon autonomic variables (HRV), on Body composition, on anthropometry, on stress & anxiety, mon food cravings, on attention & concentration

Subjects are of age group of 22-26 years

Sample size: N=45, calculated through G power- for psychological & anthropometric analysis

Study design: Single-arm pre-post experimental design.

Duration: 7 days

Intervention: Fasting will be conducted for duration of 7 days. On day one raw diet will be provided and gradually shifted to only juices 5 times a day for 5 days and 7th day subjects will be brought back to normal diet gradually.Assessments will be done on the day prior to fasting, on 4th day and then on the 7th day of fasting. But HRV reading is taken on the day prior to fasting, on 4th, 6th and 8th day. Data will be collected before the onset of intervention, after the completion of the study. Tabulation of the data will be done in Microsoft Excel. Descriptive and interferential statistics will be implied and data assessment will be done through JASP software. Value of p less than 0.05 will be considered as significant value

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
22.00 Year(s) 至 26.00 Year(s)(—)
性别
All

入选标准

  • Healthy students of age group 22-26 years Both genders will be included Students who are willing to participate in the study healthy volunteers.

排除标准

  • Any systemic diseases or illness Recent surgeries Any medications If they are involved in fasting or calorie restricted diet for last 6 months Females will be excluded if they are in their menstrual cycle during the study.

结局指标

主要结局

Heart Rate Variability HRV

时间窗: total 4 timepoints | pre assessment | on 4th day | on 6th day and | post assessment

次要结局

  • Anthropometry(Body composition)

研究者

发起方
Swami vivekananda yoga anusandhana kendra
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Swathi B S

Assistant Professor

研究点 (1)

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