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

NCT07659093 | Completed

• 2 other identifiers: 2021-872-E05-4065/MacK, Ang22-925-E05-4065/Mack,Ang
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Ketogen-based Therapeutic Diet; Metabolic Abnormalities

Keywords

ketogenic diets; intermittent fasting; metabolic health

Outcome Measures

Primary Outcomes (3)

• Concentration of HDL Cholesterol

  Fasting Blood draw to assess high-density lipoprotein cholesterol levels

  Baseline and 30 days

• Concentration of Serum Triglycerides

  Fasting blood draw to assess serum triglyceride levels

  baseline and 30-days

• Concentration of Hemoglobin A1c (HbA1c)

  Blood draw to assess HbA1c as a marker of glycemic control

  Baseline and 30 days

Study Arms (3)

Clean ketogenic Diet

EXPERIMENTAL

Participants ate low carb, under 20 g per day

Other: Diet

Intermittent fasting

EXPERIMENTAL

Participants went on a 16:8 feeding window

Other: Diet

Clean keto and IF

EXPERIMENTAL

Combined Clean keto and intermittent fasting

Other: Diet

Interventions

Diet OTHER

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

Also known as: Clean Keto, Intermittent fasting

Clean keto and IF; Clean ketogenic Diet; Intermittent fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• pregnant

Sponsors & Collaborators

• The University of Tennessee at Martin: lead

Study Sites (1)

University of Tennessee at Martin

Martin, Tennessee, 38238, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Diet

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: it was a blind study for the researcher who was analyzing the data
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 22, 2026
• Study Start: September 15, 2024
• Primary Completion: December 20, 2024
• Study Completion: February 15, 2025
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)