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Postpartum Depression (PPD)RENEWNCT07919392

Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression

A study testing Exogenous ketone supplementation, Group-Mediated Cognitive Behavioral Counseling and Structured Group Exercise in people with Postpartum Depression (PPD), run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a 16-week, fully remote, multimodal intervention combining exogenous ketone supplementation (Qitone™) with group-mediated cognitive behavioral (GMCB) counseling with structured exercise for women diagnosed with… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Depression (PPD)
What is being tested?
Exogenous ketone supplementation, Group-Mediated Cognitive Behavioral Counseling and Structured Group Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
24 Jul 2026to 30 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for enrollment:
  • Identify as female and are between 18-45 years of age. Are within 12 months postpartum following a live birth. Have a clinical diagnosis of Postpartum Depression (PPD) confirmed by a healthcare provider and/or an EPDS score ≥10 at screening. Are medically cleared by their healthcare provider for light-to-moderate physical activity. Are willing and able to participate in virtual group exercise sessions (2× weekly) and behavioral counseling sessions (1× weekly) for 16 weeks. Are willing to consume the study supplement (Qitone™ exogenous ketone or placebo) twice daily for the duration of the study. Have access to reliable internet and a device capable of participating in Zoom-based sessions. Are not currently following a ketogenic or low-carbohydrate diet. Are able and willing to complete daily glucose and ketone monitoring and wear a sleep/activity tracking ring. Are fluent in English and able to read and provide informed consent.

Who cannot join

  • Participants will be excluded from the study if any of the following apply:
  • Current pregnancy or planning to become pregnant during the study period. Breastfeeding exclusively if determined by their healthcare provider to be at risk for dietary modification or supplement use. Diagnosed with a severe psychiatric disorder (e.g., bipolar disorder, psychosis, schizophrenia) or current suicidal ideation requiring crisis intervention. History of seizure disorders, uncontrolled hypertension, or cardiovascular disease that would preclude participation in exercise. Current use of ketone supplements, GLP-1 receptor agonists, or weight loss medications. Known metabolic, renal, or hepatic disorders that may interfere with ketone metabolism or supplement safety. Participation in another interventional study within the past 30 days. Any condition that, in the judgment of the investigators, would make participation unsafe or compromise study integrity (e.g., inability to adhere to study schedule).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madison Kackley Madison Kackley, PhD contact

16142479650

Kackley.19@OSU.edu

United States1 site, 1 recruiting

  • The Ohio State University

    Columbus, Ohio, 43210-1442

    Recruiting

Other trials in United States

About this study

Official title: Restoring Emotional Needs With Exogenous Ketones for Women

The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a 16-week, fully remote, multimodal intervention combining exogenous ketone supplementation (Qitone™) with group-mediated cognitive behavioral (GMCB) counseling with structured exercise for women diagnosed with postpartum depression (PPD). The study aims to determine whether integrating biochemical, behavioral, and physical activity strategies can improve depressive symptoms, metabolic health, and psychosocial functioning during the postpartum period.

Being tested
Exogenous ketone supplementation, Matched placebo beverage, Group-Mediated Cognitive Behavioral Counseling, Structured Group Exercise
Keywords
Postpartum Depression, PPD, Women's Health, Pregnancy
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exogenous ketone supplementationDietary supplement

    Also called Qitone

    Participants will consume Qitone exogenous ketone supplement orally twice daily for 16 weeks. Supplements will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.

  • Matched placebo beverageOther

    Participants will consume an inert placebo beverage orally twice daily for 16 weeks. The placebo will be matched to the Qitone supplement in appearance and taste. It will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.

  • Group-Mediated Cognitive Behavioral CounselingBehavioural

    Also called GMCB

    Participants will attend one 30-45-minute virtual Group-Mediated Cognitive Behavioral counseling session per week for 16 weeks. Sessions will be led by trained behavioral specialists and emphasize group support, cognitive reframing, self-regulation, motivation, and adherence to exercise and nutrition recommendations. Content will progress through intensive, transition, and maintenance phases.

  • Structured Group ExerciseBehavioural

    Participants will attend two 30-minute virtual group exercise sessions per week for 16 weeks. Sessions will combine resistance and interval-based training led by certified instructors. Exercise intensity and progression will be individualized based on perceived exertion and postpartum safety. Participants will also be encouraged to achieve at least 150 minutes of moderate-to-vigorous physical activity per week.

Study groups in NCT07919392
Study groupRoleWhat they receive
Group-Mediated Cognitive Behavioral Intervention with exercise and ketone supplementActive comparatorGroup-Mediated Cognitive Behavioral Intervention with exercise and ketone supplement
Receives: Dietary Supplement: Exogenous ketone supplementation; Behavioral: Group-Mediated Cognitive Behavioral Counseling; Behavioral: Structured Group Exercise
Group-Mediated Cognitive Behavioral Intervention with exercise and placebo supplementPlacebo comparatorGroup-Mediated Cognitive Behavioral Intervention with exercise and placebo supplement
Receives: Other: Matched placebo beverage; Behavioral: Group-Mediated Cognitive Behavioral Counseling; Behavioral: Structured Group Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Edinburgh Postnatal Depression Scale Total Score

    Change in Edinburgh Postnatal Depression Scale (EPDS) total score from baseline to Week 16. The EPDS is a 10-item self-report questionnaire assessing depressive symptoms during the preceding seven days. Each item is scored from 0 to 3, yielding a total score of 0 to 30. Higher scores indicate greater depressive symptom severity. A decrease from baseline indicates improvement.

    Measured: Baseline (Week 0) and Week 16

Secondary outcomes (12)

  1. Percent Change in Total Lean Mass

    Percent change in total lean mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).

    Measured: Baseline (Week 0) and Week 16

  2. Percent Change in Total Fat Mass

    Percent change in total fat mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).

    Measured: Baseline (Week 0) and Week 16

  3. Percent Change in Body Fat Percentage

    Percent change in body fat percentage from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).

    Measured: Baseline (Week 0) and Week 16

  4. Percent Change in Body Weight

    Percent change in measured body weight from baseline to Week 16.

    Measured: Baseline (Week 0) and Week 16

  5. Percent Change in Body Mass Index

    Percent change in body mass index (BMI) from baseline to Week 16. BMI is calculated as body weight in kilograms divided by height in meters squared.

    Measured: Baseline (Week 0) and Week 16

  6. Percent Change in Waist Circumference

    Percent change in measured waist circumference from baseline to Week 16.

    Measured: Baseline (Week 0) and Week 16

  7. Percent Change in Hip Circumference

    Percent change in measured hip circumference from baseline to Week 16.

    Measured: Baseline (Week 0) and Week 16

  8. Percent Change in Fasting Blood Beta-Hydroxybutyrate Concentration

    Percent change in fasting blood beta-hydroxybutyrate concentration from baseline to Week 16. Beta-hydroxybutyrate is measured to assess circulating ketone levels.

    Measured: Baseline (Week 0) and Week 16

  9. Percent Change in Fasting Serum Glucose Concentration

    Percent change in fasting serum glucose concentration from baseline to Week 16, measured using a validated commercial assay.

    Measured: Baseline (Week 0) and Week 16

  10. Percent Change in Fasting Serum Insulin Concentration

    Percent change in fasting serum insulin concentration from baseline to Week 16, measured using a validated commercial assay.

    Measured: Baseline (Week 0) and Week 16

  11. Percent Change in Fasting Serum Cortisol Concentration

    Percent change in fasting serum cortisol concentration from baseline to Week 16, measured using a validated commercial assay.

    Measured: Baseline (Week 0) and Week 16

  12. Baseline (Week 0) and Week 16

    Percent change in serum C-reactive protein (CRP) concentration from baseline to Week 16, measured using a validated commercial assay. CRP is assessed as a marker of inflammation.

    Measured: Baseline (Week 0) and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start24 Jul 2026
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919392
Sponsor's protocol ID
2024H0455
Acronym
RENEW
Status last verified
Aug 2026
First submitted
1 Nov 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is an early-stage pilot study focused on feasibility and exploratory outcomes. At this stage, individual participant data (IPD) will not be publicly shared until all analyses are complete and findings are published. De-identified aggregate data may be shared upon reasonable request following publication, in accordance with institutional and IRB policies. If a larger, follow-up trial is initiated, a formal data-sharing plan will be developed to align with NIH and ICMJE requirements.

Publications

  • Kackley ML, Buga A, Crabtree CD, Sapper TN, McElroy CA, Focht BC, Kraemer WJ, Volek JS. Influence of Nutritional Ketosis Achieved through Various Methods on Plasma Concentrations of Brain Derived Neurotropic Factor. Brain Sci. 2022 Aug 27;12(9):1143. doi: 10.3390/brainsci12091143.

    PubMed 36138878

  • Kackley ML, Buga A, Brownlow ML, O'Connor A, Sapper TN, Crabtree CD, Robinson BT, Stoner JT, Decker DD, Soma L, Volek JS. Self-reported menses physiology is positively modulated by a well-formulated, energy-controlled ketogenic diet vs. low fat diet in women of reproductive age with overweight/obesity. PLoS One. 2024 Aug 16;19(8):e0293670. doi: 10.1371/journal.pone.0293670. eCollection 2024.

    PubMed 39150916

  • Calderon N, Betancourt L, Hernandez L, Rada P. A ketogenic diet modifies glutamate, gamma-aminobutyric acid and agmatine levels in the hippocampus of rats: A microdialysis study. Neurosci Lett. 2017 Mar 6;642:158-162. doi: 10.1016/j.neulet.2017.02.014. Epub 2017 Feb 8.

    PubMed 28189745

  • Howard LM, Flach C, Mehay A, Sharp D, Tylee A. The prevalence of suicidal ideation identified by the Edinburgh Postnatal Depression Scale in postpartum women in primary care: findings from the RESPOND trial. BMC Pregnancy Childbirth. 2011 Aug 3;11:57. doi: 10.1186/1471-2393-11-57.

    PubMed 21812968

  • Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.

    PubMed 19318144

Questions about this trial

What is this clinical trial studying?

A study testing Exogenous ketone supplementation, Group-Mediated Cognitive Behavioral Counseling and Structured Group Exercise in people with Postpartum Depression (PPD), run by Ohio State University 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Nov 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madison Kackley Madison Kackley, PhD (16142479650, Kackley.19@OSU.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Edinburgh Postnatal Depression Scale Total Score (time frame: Baseline (Week 0) and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07919392, which also lists 5 linked publications.

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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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