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Daytime vs. Delayed Eating Among Obese Individuals
NA trial testing Eating Condition in Obesity in 38 participants. Completed in 2 March 2023.
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 38 |
| Start date | 7 February 2018 |
| Primary completion | 2 March 2023 |
| Estimated completion | 2 March 2023 |
| Sites | 1 location across United States |
University of Pennsylvania
Adults 21 to 50, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
changes in body mass, as measured by a calibrated digital scale, will be explored.
| Group | Value | 95% CI |
|---|---|---|
| Daytime Eating Condition | -2.1067 | ± 3.8373 |
| Delayed Eating Condition | -2.1887 | ± 2.7237 |
changes in measures of total body fat, as measured by a DEXA scan, will be explored.
| Group | Value | 95% CI |
|---|---|---|
| Daytime Eating Condition | -0.3300 | ± 1.8217 |
| Delayed Eating Condition | -0.4833 | ± 1.2862 |
Changes in resting energy expenditure values will be explored.
| Group | Value | 95% CI |
|---|---|---|
| Daytime Eating Condition | -32.4723 | ± 260.8070 |
| Delayed Eating Condition | 47.0390 | ± 240.9396 |
Respiratory quotient (RQ) was measured with a Parvo-Medics metabolic cart. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body, when the body is in a steady state.
| Group | Value | 95% CI |
|---|---|---|
| Daytime Eating Condition | -0.203 | ± 0.0607 |
| Delayed Eating Condition | -0.0197 | ± 0.6499 |
Time frame: We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Daytime Eating Condition | Delayed Eating Condition | Non-randomized Participants |
|---|---|---|---|---|
| non-infected phlebitis | Skin and subcutaneous tissue disorders | — | — | — |
| vomiting | Gastrointestinal disorders | — | — | — |
| headache | General disorders | — | — | — |
| hypoglycemia | Endocrine disorders | — | — | — |
| sub-conjunctive hemorrhage | Eye disorders | — | — | — |
| panic attack | Psychiatric disorders | — | — | — |
| vein infiltration | Skin and subcutaneous tissue disorders | — | — | — |
| pain in upper left extremity | Injury, poisoning and procedural complications | — | — | — |
Data from ClinicalTrials.gov NCT03354169 adverse events section.
The randomized, cross-over design study is designed to determine how timing of eating affects weight, adiposity, energy metabolism, and gene expression. Obese participants will be provided isocaloric meals and snacks to be consumed in one of two prescribed eating conditions -- daytime eating and delayed eating.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing