The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- weight
研究概览
简要总结
The goal of this randomized controlled trial is to learn about the short-term effects of an 8-hour time-restricted eating (TRE) protocol combined with caloric restriction in women aged 18-55 years with prediabetes.
The main question it aims to answer is:
Does an 8-hour time-restricted eating protocol combined with caloric restriction improve anthropometric measurements and metabolic parameters more than caloric restriction alone in women with prediabetes?
Researchers will compare the time-restricted eating (IF) group to a control group following a conventional calorie-restricted diet with no time restriction, to see whether time-restricted eating provides additional benefit beyond that of caloric deficit alone.
Participants will:
Be randomly assigned to either the IF group (all meals consumed within an 8-hour window, 16-hour daily fast) or the control group (calorie-restricted diet, no time restriction), both matched for a 500 kcal/day energy deficit Follow their assigned diet for 5 weeks, with daily dietary reminders and support Undergo assessments at baseline and at the end of the 5-week intervention, including body weight, BMI, waist/hip circumference, body composition (bioimpedance), and fasting blood tests (glucose, insulin, HbA1c, total cholesterol, HDL-C, LDL-C, triglycerides)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age between 18 and 55 years
- •Diagnosis of prediabetes (fasting plasma glucose 100-125 mg/dL and/or HbA1c 5.7%-6.4%)
- •Willingness and ability to attend in-person dietitian counseling at the Family Health Center Unit and to use WhatsApp for daily follow-up and reporting Provision of written informed consent
排除标准
- •Pregnancy or lactation
- •Use of antidiabetic or immunosuppressive medications
- •Presence of endocrine disorders
- •History of malignancy or organ transplantation
- •Prior bariatric surgery
结局指标
主要结局
weight
时间窗: 5 weeks
weight and height will be combined to report BMI in kg/m\^2
次要结局
- Waist circumference (WC)(5 weeks)
- lipid parameters(5 weeks)
研究者
Yasemin Cayir
Prof. Dr.
Ataturk University
