Effect of intermittent fasting vs regular diet on weight reduction and biomarkers in healthy adults with obesity in Chengalpattu district: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in weight loss from baseline to week 4 in healthy adults with obesity.
研究概览
简要总结
Summary
Introduction
The proposed study will investigate intermittent fasting IF specifically the 16 hours of fasting and 8 window period protocol as a non pharmacological intervention for obesity. In light of the growing global obesity epidemic particularly in India where approximately 25 percentage of the population is overweight or obese the study will explore the link between obesity and non communicable diseases NCDs such as diabetes cardiovascular disease and mental health disorders. The 16 hours of fasting and 8 window period protocol which restricts food intake to an 8 hour window is anticipated to improve fat metabolism enhance insulin sensitivity and reduce inflammation via mechanisms such as ketogenesis and autophagy. The study will build on existing evidence from previous research on various IF protocols including alternate-day fasting and 5 days of fasting and 2 days of add libitum feed which have demonstrated positive effects on weight management and biomarkers like triacylglycerol C reactive protein and leptin.
Methodology
The study will be conducted as a randomized controlled trial in Chengalpattu Tamil Nadu India and will recruit 40 participants aged 18 to 45 years with a BMI above 25. Participants will be screened using strict inclusion and exclusion criteria to minimize confounding factors such as preexisting metabolic disorders acute illness or involvement in other weight loss programs. The trial will follow an open label design and eligible participants will be randomized using block randomization with allocation concealment via SNOSE envelopes.
Participants will be randomly assigned into two groups
The intervention group will follow the 16 hours of fasting and 8 hours of window period intermittent fasting protocol.
The control group will continue with their usual diet.
Both groups will receive dietary counselling weekly telephonic follow-ups, and will be instructed to maintain diet diaries to assess compliance. Adherence will be supported through mobile health interventions with a minimum adherence threshold of 85 percentage set to ensure the validity of outcomes.
Prior to randomization all participants will undergo detailed baseline assessments which will include
Anthropometric measurements
Blood biomarker analysis including high sensitivity C reactive protein or hsCRP
Body composition analysis using the InBody770 device
Psychometric evaluations, including
Short form 36 for quality of life
WHO-5 for psychological wellbeing
Fatigue Assessment Scale
Global Physical Activity Questionnaire
Eating Disorder Examination Questionnaire
Blood samples will be collected after a 7 to 8 hour fast on Day 0 and Day 30 to assess fasting blood sugar lipid profile and hsCRP which is a recognized biomarker of systemic inflammation and cardiovascular risk.
These comprehensive baseline and endpoint measures will enable a multidimensional evaluation of the anticipated physiological and psychological impacts of intermittent fasting in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals who are willing to participate and who are willing to provide consent to participate in the study.
- •Individuals of age 18 years to 45 years.
- •Either male or female.
- •Individuals with BMI above
- •Individual should be in and around Chengalpattu region.
排除标准
- •Individual with cardiovascular diseases, metabolic disorders, diabetes mellitus, peptic ulcers, cognitive impairment, congenital anomalies, physically challenged, cancer, renal /liver impairment, pregnant and breastfeeding women or any eating disorders b.
- •Any Acute illness c.
- •HbA1c more than 6.5% .
- •Individual who underwent major surgical procedures in the last 3 months.
- •Individuals taking supplements or any other weight loss treatment such as ayurvedic, cryotherapy f.
- •Individuals who are engaged in gym activities, shift work, or heavy labor tasks.
- •Participation in another interventional trial.
结局指标
主要结局
Change in weight loss from baseline to week 4 in healthy adults with obesity.
时间窗: Change in weight loss from baseline to week 4 in healthy adults with obesity.
次要结局
- Change in quality of life, lipid profile, well-being, fatigue in healthy adults with obesity.
研究者
U Idayakshini
SRM Medical College Hospital Research Centre