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临床试验/NCT07713394
NCT07713394已完成不适用

The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study

Ataturk University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月1日最近更新:
适应症

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

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

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

Yasemin Cayir

Prof. Dr.

Ataturk University

研究点 (1)

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