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Completed

NCT Number: NCT07659093

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

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.

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Key information

Conditions

Healthy Behavior Fasting Feeding Behavior Intermittent Fasting Ketogen-based Therapeutic Diet Metabolic Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee at Martin

Martin, Tennessee, 38238, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • pregnant

Treatment and study plan

Diet

Other

intervention was either clean keto, intermittent fasting 16:8 schedule or a combination of both

Other names: Clean Keto, Intermittent fasting

Primary outcomes

  1. Concentration of HDL Cholesterol

    Time frame: Baseline and 30 days

    Fasting Blood draw to assess high-density lipoprotein cholesterol levels

  2. Concentration of Serum Triglycerides

    Time frame: baseline and 30-days

    Fasting blood draw to assess serum triglyceride levels

  3. Concentration of Hemoglobin A1c (HbA1c)

    Time frame: Baseline and 30 days

    Blood draw to assess HbA1c as a marker of glycemic control

Sponsors and collaborators

Lead sponsor

The University of Tennessee at Martin

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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