Recruiting

Qitone™ & GMCB

Sponsor:

Ohio State University

Code:

NCT07919392

Conditions

Postpartum Depression (PPD)

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Exogenous ketone supplementation

Matched placebo beverage

Group-Mediated Cognitive Behavioral Counseling

Structured Group Exercise

Study Details

Brief 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 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.

Conditions

Postpartum Depression (PPD)

Study ID

NCT07919392

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Group-Mediated Cognitive Behavioral Intervention with exercise and ketone supplement

Group-Mediated Cognitive Behavioral Intervention with exercise and ketone supplement

placebo comparator: Group-Mediated Cognitive Behavioral Intervention with exercise and placebo supplement

Group-Mediated Cognitive Behavioral Intervention with exercise and placebo supplement

Interventions

Exogenous ketone supplementation

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 beverage

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 Counseling

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 Exercise

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.

Primary outcome measure

  • Change in Edinburgh Postnatal Depression Scale Total Score [ Time Frame: Baseline (Week 0) and Week 16 ]

Central Contacts and Locations

Central contacts

Madison Kackley Madison Kackley, PhD

16142479650Kackley.19@OSU.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210-1442

More Information

Sponsor

Ohio State University

Last update posted

Nov 5, 2026

Last verified

Aug, 2026

Keywords

  • Postpartum Depression
  • PPD
  • Women's Health
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.