Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
NCT07919392, Not applicable, Recruiting, Ohio State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression | ClinicalTrials.gov |
| NCT number | NCT07919392 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ohio State University | ClinicalTrials.gov |
| Conditions | Postpartum Depression (PPD) | ClinicalTrials.gov |
| Interventions | Exogenous ketone supplementation, Matched placebo beverage, Group-Mediated Cognitive Behavioral Counseling, Structured Group Exercise | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Edinburgh Postnatal Depression Scale Total Score | Baseline (Week 0) and Week 16 | Change in Edinburgh Postnatal Depression Scale (EPDS) total score from baseline to Week 16. The EPDS is a 10-item self-report questionnaire assessing depressive symptoms during the preceding seven days. Each item is scored from 0 to 3, yielding a total score of 0 to 30. Higher scores indicate greater depressive symptom severity. A decrease from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Percent Change in Total Lean Mass | Baseline (Week 0) and Week 16 | Percent change in total lean mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA). | ClinicalTrials.gov |
| Secondary | Percent Change in Total Fat Mass | Baseline (Week 0) and Week 16 | Percent change in total fat mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA). | ClinicalTrials.gov |
| Secondary | Percent Change in Body Fat Percentage | Baseline (Week 0) and Week 16 | Percent change in body fat percentage from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA). | ClinicalTrials.gov |
| Secondary | Percent Change in Body Weight | Baseline (Week 0) and Week 16 | Percent change in measured body weight from baseline to Week 16. | ClinicalTrials.gov |
| Secondary | Percent Change in Body Mass Index | Baseline (Week 0) and Week 16 | Percent change in body mass index (BMI) from baseline to Week 16. BMI is calculated as body weight in kilograms divided by height in meters squared. | ClinicalTrials.gov |
| Secondary | Percent Change in Waist Circumference | Baseline (Week 0) and Week 16 | Percent change in measured waist circumference from baseline to Week 16. | ClinicalTrials.gov |
| Secondary | Percent Change in Hip Circumference | Baseline (Week 0) and Week 16 | Percent change in measured hip circumference from baseline to Week 16. | ClinicalTrials.gov |
| Secondary | Percent Change in Fasting Blood Beta-Hydroxybutyrate Concentration | Baseline (Week 0) and Week 16 | Percent change in fasting blood beta-hydroxybutyrate concentration from baseline to Week 16. Beta-hydroxybutyrate is measured to assess circulating ketone levels. | ClinicalTrials.gov |
| Secondary | Percent Change in Fasting Serum Glucose Concentration | Baseline (Week 0) and Week 16 | Percent change in fasting serum glucose concentration from baseline to Week 16, measured using a validated commercial assay. | ClinicalTrials.gov |
| Secondary | Percent Change in Fasting Serum Insulin Concentration | Baseline (Week 0) and Week 16 | Percent change in fasting serum insulin concentration from baseline to Week 16, measured using a validated commercial assay. | ClinicalTrials.gov |
| Secondary | Percent Change in Fasting Serum Cortisol Concentration | Baseline (Week 0) and Week 16 | Percent change in fasting serum cortisol concentration from baseline to Week 16, measured using a validated commercial assay. | ClinicalTrials.gov |
| Secondary | Baseline (Week 0) and Week 16 | Baseline (Week 0) and Week 16 | Percent change in serum C-reactive protein (CRP) concentration from baseline to Week 16, measured using a validated commercial assay. CRP is assessed as a marker of inflammation. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)