Restoring Emotional Balance With Ketones for Women After Birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a fully remote, 16-week intervention for women aged 18-45 within a year after childbirth who have postpartum depression. Participants will receive either exogenous ketones (Qitone) or a matched placebo, alongside group-mediated cognitive behavioral counseling and structured online exercise sessions. The study will monitor depressive symptoms, metabolic health, and psychosocial functioning, using daily glucose and ketone monitoring and wearable sleep/activity data. It aims to determine feasibility, acceptability, and preliminary efficacy of combining biochemical, behavioral, and physical activity strategies in the postpartum period. The trial is conducted at The Ohio State University with virtual participation favored.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Madison Kackley Madison Kackley, PhD
• Email: Kackley.19@OSU.edu
• Phone: 16142479650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.