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CTRI Number  CTRI/2024/10/075275 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Cluster Randomized Trial 
Public Title of Study   A Study on the Effects of a 5 Day Home-Based Fasting Program on University Students Health and Well-Being 
Scientific Title of Study   Feasibility and Effects of a 5 Day Home Based Fasting Intervention in University Students: A Pilot Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchika Golani 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Naturopathy and Yogic Sciences B Block, Faculuty Room, 3rd Floor, SGT University Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9752308917  
Fax    
Email  ruchika_fnys@sgtuniversity.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchika Golani 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Naturopathy and Yogic Sciences B Block, Faculuty Room, 3rd Floor, SGT University Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9752308917  
Fax    
Email  ruchika_fnys@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Dr Ruchika Golani 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Naturopathy and Yogic Sciences B Block, Faculuty Room, 3rd Floor, SGT University Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9752308917  
Fax    
Email  ruchika_fnys@sgtuniversity.org  
 
Source of Monetary or Material Support  
SGT University Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India. 
 
Primary Sponsor  
Name  SGT University 
Address  Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchika Golani  SGT University  Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.
Gurgaon
HARYANA 		 9752308917

ruchika_fnys@sgtuniversity.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE FOR FACULTY OF NATUROPATHY AND YOGIC SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  modifiable risk factors management  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5 days of Fasting Therapy. .  day wise fasting Protocol for 5 days fasting Day Meals Hydration Supportive Measures Day 1 Transition Day - Light, easily digestible meals - Midday: Fresh fruit/light yoghurt smoothie with nuts & berries/Avocado salad with olive oil dressing & steamed vegetables - Dinner: Vegetable broth or soup with coconut oil Herbal teas and plenty of water -Relaxation techniques (e.g., meditation or yoga) -Enema in the morning -Journaling Days 2-4 Liquid Fasting - Morning: Warm lemon water or herbal tea with honey - Midday: Freshly prepared vegetable broth with a small amount of olive oil - Afternoon: Herbal tea - Evening: Vegetable broth with coconut oil/ghee Drink plenty of water - Daily liver packs (e.g., castor oil packs) for detoxification - Gentle stretching, deep breathing, abdominal breathing, meditation - Hot foot bath with Epsom salt at bedtime - Journaling Day 5 Reintroduction Day - Gradual reintroduction of solid foods - Breakfast: Whey water with honey - Midday: Steamed apple - Dinner: Steamed vegetables with coconut oil & a small portion of amaranth or brown rice khichdi Continue with herbal teas and water - Reflection through journaling or meditation - Gentle physical activity such as walking or stretching  
Comparator Agent  waitlist control group  fasting therapy for 5 days same as intervention group to be administered after completion of 5 days fasting by intervention group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Age: Participants must be between 18 and 30 years old.
Enrollment: Must be currently enrolled as a university student.
Willingness to fast: Participants must express a willingness to adhere to a 5-day fasting protocol, including the transition, liquid fasting, and reintroduction phases.
Health Status: Must be generally healthy, as indicated by self-reported medical history (no significant chronic illnesses such as diabetes, heart disease, or other metabolic conditions).
Internet Access: Must have access to a smartphone or computer with internet for monitoring, virtual check-ins, and self-reporting via surveys or apps.
Informed Consent: Must provide written informed consent to participate in the study and agree to comply with the study protocol, including daily monitoring of physiological and psychological outcomes.
Body Mass Index (BMI): Participants should have a BMI between 18.5 and 29.9 kg/m² (healthy or overweight range). 
 
ExclusionCriteria 
Details  Existing Medical Conditions: Any diagnosed metabolic disorders (e.g., diabetes, thyroid disease), cardiovascular conditions, or gastrointestinal diseases that could be negatively affected by fasting.
Pregnancy or Lactation: Pregnant or breastfeeding women will be excluded for safety reasons.
Eating Disorders: A current or past diagnosis of any eating disorder, such as anorexia, bulimia, or binge-eating disorder.
Medication Use: Regular use of medication that affects metabolism, blood sugar, or appetite (e.g., insulin, corticosteroids, appetite suppressants).
Allergies or Food Intolerances: Any severe allergies or intolerances to foods included in the fasting or reintroduction protocols (e.g., vegetable broths, olive oil, ghee, coconut oil).
Recent Major Surgery or Injury: Participants who have undergone surgery or suffered a major injury in the past 3 months that may interfere with fasting or physical well-being.
Mental Health Conditions: Current diagnosis of severe mental health conditions (e.g., major depressive disorder, anxiety disorder, bipolar disorder) that may be exacerbated by fasting.
Smoking or Alcohol Abuse: Regular smokers or those with a history of substance or alcohol abuse in the past 6 months.
Participation in Other Studies: Concurrent participation in another clinical trial or health intervention that may interfere with fasting outcomes or data collection. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
feasibility of the fasting protocol and any adverse events reported during the intervention.Feasibility will be determined by examining adherence rates, participant retention, and overall satisfaction with the fasting protocol. Additionally, safety will be evaluated by monitoring any adverse events or fasting crisis symptoms.  Daily for 5 days during the intervention in both control and intervention group. 
 
Secondary Outcome  
Outcome  TimePoints 
weight, BMI, & blood glucose, ketone bodies.
daily self-reports of stress, anxiety, & mood 		 o Baseline & after 5 days (Pre- & post-intervention) changes in weight, waist circumference, & glucose/ketone levels will be analysed
o Daily during 5 intervention days self-reported physical well-being (PWB) & emotional well-being (EWB) scores will be analysed 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study Title:

Feasibility and Effects of a 5-Day Home-Based Fasting Intervention in University Students: A Pilot Study

Study Design:

This is a cluster-randomized, waitlist-controlled pilot trial aimed at assessing the feasibility, safety, and preliminary physiological and psychological effects of a 5-day home-based fasting intervention in university students.

Study Objectives:

  1. Primary Objective: To evaluate the feasibility and safety of a 5-day home-based fasting protocol among university students.
  2. Secondary Objectives:
    • To assess physiological outcomes, including changes in body weight, body mass index (BMI), waist circumference, blood glucose, and ketone levels.
    • To evaluate psychological well-being, focusing on mood, stress, and emotional well-being, using validated questionnaires.

Inclusion Criteria:

  • University students aged 18-30 years.
  • Generally healthy (no chronic diseases).
  • Willingness to adhere to the 5-day fasting protocol.
  • Access to the internet for self-reporting and virtual monitoring.

Exclusion Criteria:

  • Diagnosed with metabolic disorders, cardiovascular conditions, or gastrointestinal diseases.
  • Pregnant or lactating women.
  • History of eating disorders or severe mental health conditions.
  • Currently taking medications affecting metabolism or appetite.

Intervention:

Participants in the intervention group will follow a 5-day fasting protocol at home, including a transition day, 3 days of liquid fasting, and a reintroduction day. The waitlist control group will begin fasting after the first group completes the intervention.

Sample Size:

Approximately 30 university students, with two clusters of 20 each (one intervention, one control).

Outcomes:

  1. Primary Outcomes:
    • Feasibility based on adherence rates (≥80%) and retention (≤30% dropout).
    • Safety is assessed by adverse events and blood glucose monitoring.
  2. Secondary Outcomes:
    • Changes in weight, BMI, and blood glucose/ketone levels.
    • Emotional well-being and psychological health were assessed through self-reports.

Duration:

The study will last for 5 days, with follow-up assessments post-intervention.

 
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