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

Part of paid clinical trials in Martin, Tennessee.

Sponsor
The University of Tennessee at Martin
Study ID
NCT07659093
Status
Completed

Conditions

  • Healthy
  • Ketogen-based Therapeutic Diet
  • Metabolic Abnormalities

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2024
Status verified
Jun 2026
Primary completion
Dec 20, 2024
Completion
Feb 15, 2025

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Clean ketogenic Diet
    Participants ate low carb, under 20 g per day
  • Experimental: Intermittent fasting
    Participants went on a 16:8 feeding window
  • Experimental: Clean keto and IF
    Combined Clean keto and intermittent fasting

Primary Outcome Measure

Concentration of HDL Cholesterol [ Time Frame: Baseline and 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee at MartinMartinTennessee38238-

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By research site
University of Tennessee at Martin· Martin, TN

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