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Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression

Key facts

Who runs it
Ohio State University
Where
Columbus, United StatesSee the site
Trial code
Status
Recruiting
People taking part
40 people, planned
Started
24 Jul 2026
Expected to end
30 Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Exogenous ketone supplementation
  • Matched placebo beverage
  • Group-Mediated Cognitive Behavioral Counseling
  • Structured Group Exercise
Record updated
5 November 2026

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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 take part

  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Where in United States

  • The Ohio State UniversityColumbus, United StatesContact: Madison Kackley Madison Kackley, PhDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Group-Mediated Cognitive Behavioral Intervention with exercise and ketone supplementExisting treatment, for comparison

    Treatment: Exogenous ketone supplementation, Group-Mediated Cognitive Behavioral Counseling, and Structured Group Exercise

  • Group-Mediated Cognitive Behavioral Intervention with exercise and placebo supplementPlacebo, for comparison

    Treatment: Matched placebo beverage, Group-Mediated Cognitive Behavioral Counseling, and Structured Group Exercise

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Restoring Emotional Needs With Exogenous Ketones for Women
Fit questions
Built from NCT07919392, who can take part
Record updated
5 November 2026