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临床试验/NCT07659093
NCT07659093已完成不适用

Comparing Intermittent Fasting, Clean Ketogenic Diet, and Their Combined Effects on Body Composition, Cardiometabolic Markers, and Metabolic Health

The University of Tennessee at Martin1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2024年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
1
主要终点
Concentration of HDL Cholesterol

研究概览

简要总结

A cross-study analysis combined data from two sequential pre-post intervention studies conducted at the University of Tennessee at Martin, yielding a three-arm design comprising intermittent fasting alone (n = 16), clean ketogenic diet alone (n = 22), and combined clean ketogenic diet with intermittent fasting (n = 41). The clean ketogenic diet restricted carbohydrate intake to 20 grams per day from whole unprocessed sources and eliminated refined sugars, high-fructose corn syrup, and ultra-processed foods.

详细描述

The intermittent fasting protocol employed a 16:8 time-restricted eating window. Paired-samples t-tests examined within-group pre-to-post changes. One-way analyses of variance with Tukey post-hoc comparisons examined between-group differences in magnitude of change. Effect sizes are reported as Hedges' g for within-group comparisons and eta-squared for between-group comparisons. An independent samples t-test compared glycosylated hemoglobin changes between the intermittent fasting and combined groups. Spearman and Kendall correlations examined associations between fat mass and cardiometabolic change.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

it was a blind study for the researcher who was analyzing the data

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Clean ketogenic Diet

Experimental

Participants ate low carb, under 20 g per day

干预措施: Diet (Other)

Intermittent fasting

Experimental

Participants went on a 16:8 feeding window

干预措施: Diet (Other)

Clean keto and IF

Experimental

Combined Clean keto and intermittent fasting

干预措施: Diet (Other)

结局指标

主要结局

Concentration of HDL Cholesterol

时间窗: Baseline and 30 days

Fasting Blood draw to assess high-density lipoprotein cholesterol levels

Concentration of Serum Triglycerides

时间窗: baseline and 30-days

Fasting blood draw to assess serum triglyceride levels

Concentration of Hemoglobin A1c (HbA1c)

时间窗: Baseline and 30 days

Blood draw to assess HbA1c as a marker of glycemic control

次要结局

未报告次要终点

研究者

发起方
The University of Tennessee at Martin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angie MacKewn

Professor

The University of Tennessee at Martin

研究点 (1)

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