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Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Restoring Emotional Needs With Exogenous Ketones for Women
Who can join
Ages 18 to 45 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
About the study
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.
What is being tested
- Exogenous ketone supplementation (dietary supplement)
- Matched placebo beverage (other)
- Group-Mediated Cognitive Behavioral Counseling (behavioral)
- Structured Group Exercise (behavioral)
Sponsor: Ohio State University · Participants: 40 · Started: Jul 24, 2026
Contact the study team
- Madison Kackley Madison Kackley, PhD · Phone: 16142479650
Official record on ClinicalTrials.gov — NCT07919392
Locations in the U.S.
| Ohio | The Ohio State University, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.