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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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