HealthyNCT07659093
Comparing Intermittent Fasting, Clean Ketogenic Diet, and Their Combined Effects on Body Composition, Cardiometabolic Markers, and Metabolic Health
A study testing Diet in people with Healthy and Ketogen-based Therapeutic Diet, run by The University of Tennessee at Martin at 1 site in United States.
Trial 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 =… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Ketogen-based Therapeutic Diet, Metabolic Abnormalities
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee at Martin
Martin, Tennessee, 38238
About this study
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.
Read the 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.
- Being tested
- Diet
- Keywords
- ketogenic diets, intermittent fasting, metabolic health
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called Clean Keto, Intermittent fasting
intervention was either clean keto, intermittent fasting 16:8 schedule or a combination of both
| Study group | Role | What they receive |
|---|---|---|
| Clean ketogenic Diet | Experimental | Participants ate low carb, under 20 g per day Receives: Other: Diet |
| Intermittent fasting | Experimental | Participants went on a 16:8 feeding window Receives: Other: Diet |
| Clean keto and IF | Experimental | Combined Clean keto and intermittent fasting Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HDL Cholesterol
Fasting Blood draw to assess high-density lipoprotein cholesterol levels
Measured: Baseline and 30 days
Concentration of Serum Triglycerides
Fasting blood draw to assess serum triglyceride levels
Measured: baseline and 30-days
Concentration of Hemoglobin A1c (HbA1c)
Blood draw to assess HbA1c as a marker of glycemic control
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Sep 2024
- Primary completion20 Dec 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- three arm design comparing 3 interventions (low carb, intermittent fasting, combined) between group design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee at Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angie MacKewn, The University of Tennessee at Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659093
- Sponsor's protocol ID
- 2021-872-E05-4065/MacK, Ang
- Other IDs
- 22-925-E05-4065/Mack,Ang
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we will share all data and instruments, but we don't have a plan for an IPD right now
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intermittent Fasting, Clean Ketogenic Diet, and Their Combined Effects on Body Composition, Cardiometabolic Markers, and Metabolic Health
- ClinicalTrials.gov ID
- NCT07659093
- Acronym / sponsor ID
- 2021-872-E05-4065/MacK, Ang
- Keywords
- ketogenic diets, intermittent fasting, metabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- The University of Tennessee at MartinUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- three arm design comparing 3 interventions (low carb, intermittent fasting, combined) between group design
| Arm | Type | Receives |
|---|---|---|
| Clean ketogenic Diet | Experimental | Other: DietParticipants ate low carb, under 20 g per day |
| Intermittent fasting | Experimental | Other: DietParticipants went on a 16:8 feeding window |
| Clean keto and IF | Experimental | Other: DietCombined Clean keto and intermittent fasting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAlso: Clean Keto, Intermittent fastingintervention was either clean keto, intermittent fasting 16:8 schedule or a combination of both | Other | Clean keto and IF, Clean ketogenic Diet, Intermittent fasting |
Primary outcome
Concentration of HDL Cholesterol
Time frame: Baseline and 30 days
Fasting Blood draw to assess high-density lipoprotein cholesterol levels
Concentration of Serum Triglycerides
Time frame: baseline and 30-days
Fasting blood draw to assess serum triglyceride levels
Concentration of Hemoglobin A1c (HbA1c)
Time frame: Baseline and 30 days
Blood draw to assess HbA1c as a marker of glycemic control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided. we will share all data and instruments, but we don't have a plan for an IPD right now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy and Ketogen-based Therapeutic Diet, run by The University of Tennessee at Martin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HDL Cholesterol (time frame: Baseline and 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.