Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07659093
Enrollment
79
Registered
2026-06-22
Start date
2024-09-15
Completion date
2025-02-15
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Ketogen-based Therapeutic Diet, Metabolic Abnormalities

Keywords

ketogenic diets, intermittent fasting, metabolic health

Brief summary

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.

Detailed description

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.

Interventions

OTHERDiet

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

Sponsors

The University of Tennessee at Martin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

three arm design comparing 3 interventions (low carb, intermittent fasting, combined) between group design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\-

Exclusion criteria

* pregnant

Design outcomes

Primary

MeasureTime frameDescription
Concentration of HDL CholesterolBaseline and 30 daysFasting Blood draw to assess high-density lipoprotein cholesterol levels
Concentration of Serum Triglyceridesbaseline and 30-daysFasting blood draw to assess serum triglyceride levels
Concentration of Hemoglobin A1c (HbA1c)Baseline and 30 daysBlood draw to assess HbA1c as a marker of glycemic control

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026