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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK117488 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
The study consists of the following phases - screening, assessment visit 1, eating condition 1, assessment visit 2, a wash-out period, assessment visit 3, eating condition 2 and assessment visit 4, as discussed in detail below. The assessment visits will all consist of the same procedures and will take place at the Center for Human Phenomic Science (CHPS) of the Hospital of the University of Pennsylvania before and after each of the eating conditions (four times total). The four 28-hour inpatient assessments will consist of blood draws, adipose (fat) tissue sampling, a dual energy X-ray absorptiometry (DEXA) scan, and a resting metabolic rate test.
During the screening period in order to determine eligibility, participants must complete a 2-part screening visit; This includes:
During the screening period, participants will also be asked to keep a 10-day food log where they will record all food and beverages consumed and their sleep and exercise schedule. Participants will be asked to wear an Actigraph wrist watch at this time.
Following successful completion of the screening period, participants will complete the first of 4 assessment visits. All assessment visits will follow the same protocol.
Assessment Visit Day 1 Procedures:
The visit will include 28 hours (overnight) spent at the CHPS, where meals and snacks will be provided. At each of the assessment visits participants will be given a urine drug screening and, if appropriate, a pregnancy test. The lights will be dim in the hospital room to control for light.
Participants will arrive at 7:00 am. Starting at 8:00 am, blood will be drawn every four hours. From this blood gene expression and hormones related to metabolism, eating, and sleep will be measured.
Following the first blood draw, resting metabolic rate is measured for 45 minutes. Lunch is then provided, followed by a measurement of body composition using a DEXA scan. Next, the adipose tissue sampling procedure will begin. Lastly, the participants will complete a series of cognitive tests administered on a laptop.
Participants will be provided meals and snacks during their visit and are free to watch television or participate in other sedentary pastimes while they are there.
Assessment Visit Day 2 Procedures:
After an overnight fast, participants will undergo the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGT) on the morning of day 2.
Following the FSIGT test, participants will be served a meal and during the first assessment visit, participants will be randomly assigned to start with one of two eating conditions for the next 8 weeks: 1) Daytime or 2) Delayed. Following randomization, participants will be discharged from CHPS and begin eating condition 1.
If participants are assigned to the daytime eating condition first, they will be asked to consume all of their meals and snacks each day between 8:00 am and 7:00 pm. If they are assigned to the delayed eating condition first, they will be asked to consume all of their meals and snacks between 12 noon and 11:00 pm each day. Participants will eat on this schedule for 8 weeks. During the two, 8-week eating periods, all of the meals and snacks will be provided by the research kitchen. During the eating conditions, participants will be asked to complete daily self-report queries concerning their adherence to the food, sleep, and physical activity requirements of the study.
Following eating condition 1, participants will return for assessment visit 2. This assessment visit follows the same procedures as all other assessment visits. Following assessment visit 2, participants will begin their 2 week washout period where they are instructed to eat as they normally would whenever they like. Following the two-week washout period, participants will return for assessment visit 3, after which they will begin eating condition 2. Following 8 weeks of eating condition 2 participants will return for their final visit, assessment visit 4. After this final assessment, participation in the study will be complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daytime Eating Condition | Experimental | Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900. |
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| Delayed Eating Condition | Experimental | Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300. |
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| Withdrawn before randomization | Other | Two participants completed the screening process and started the first inpatient assessment visit but were withdrawn prior to completion of the assessment visit and were not randomized to start the intervention. They were not included in data analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eating Condition | Behavioral | Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass (Weight) | changes in body mass, as measured by a calibrated digital scale, will be explored. | pre-post changes between the daytime and delayed eating conditions (each 8 weeks long) |
| Adiposity - Total Body Fat | changes in measures of total body fat, as measured by a DEXA scan, will be explored. | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
| Energy Homeostasis Outcomes - REE | Changes in resting energy expenditure values will be explored. | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
| Energy Homeostasis - Respiratory Quotient | 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. | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Allison, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daytime Eating (8 Wks), Followed by Washout (2 Wks), Followed by Delayed Eating (8wks) | Participants were asked to eat on the Daytime condition first, eating all of their meals and snacks, as provided by the study, between 0800 and 1900 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Delayed condition when they ate their meals between 1200 and 2300 hr for 8 weeks. |
| FG001 | Delayed Eating (8 Wks), Followed by Washout (2 Wks), Followed by Daytime Eating (8wks) | Participants were asked to eat on the Delated condition first, eating all of their meals and snacks, as provided by the study, between 1200 and 2300 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Daytime condition when they ate their meals between 0800 and 1900 hr for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All study participants are described as they all were intended to complete both eating conditions. Two were withdrawn after their first assessment visit but before randomization occurred.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800h and 1900h during the Daytime condition and between 1200h and 2300h in the Delayed condition. Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will then have a 2-week washout period. They will complete the alternative eating condition for 8 weeks during eating condition 2. Two participants were withdrawn from the study after assessment visit 1 and were not randomized. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass (Weight) | changes in body mass, as measured by a calibrated digital scale, will be explored. | Thirty participants completed the two eating conditions; six were withdrawn prior to completing at least two assessment visits. | Posted | Mean | Standard Deviation | kg | pre-post changes between the daytime and delayed eating conditions (each 8 weeks long) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daytime Eating Condition | Adverse events that were experienced during the pre- or post-daytime eating condition inpatient assessment visits are reported in this group. No AEs were reported outside of the assessment visits. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-infected phlebitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to FSIGT test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly C. Allison, PhD | University of Pennsylvania | 215-898-2823 | kca@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Sep 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 2, 2022 | Sep 27, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized within subjects, cross-over design
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| No Intervention; withdrawn before randomization | Other | These participants were withdrawn and did not receive an intervention. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Delayed Eating Condition |
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300. Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2. |
|
|
| Primary | Adiposity - Total Body Fat | changes in measures of total body fat, as measured by a DEXA scan, will be explored. | Posted | Mean | Standard Deviation | percentage of total body mass | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
|
|
|
| Primary | Energy Homeostasis Outcomes - REE | Changes in resting energy expenditure values will be explored. | Posted | Mean | Standard Deviation | kcals per day | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
|
|
|
| Primary | Energy Homeostasis - Respiratory Quotient | 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. | Posted | Mean | Standard Deviation | ratio of CO2 produced/O2 consumed | pre-post changes between the daytime and delayed eating conditions (8 weeks). |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 6 |
| 36 |
| EG001 | Delayed Eating Condition | Adverse events that were experienced at the pre- or post- Delayed Eating Condition assessment visits are presented in this group. No AEs were reported outside of the assessment visits. | 0 | 36 | 0 | 36 | 6 | 36 |
| EG002 | Non-randomized Participants | Two participants experienced adverse events at their first inpatient assessment visits and withdrew from the study. There were not randomized to an eating condition (this occurred at the conclusion of assessment visit 1). | 0 | 2 | 0 | 2 | 2 | 2 |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| hypoglycemia | Endocrine disorders | Non-systematic Assessment | related to FSIGT test |
|
| sub-conjunctive hemorrhage | Eye disorders | Non-systematic Assessment |
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| panic attack | Psychiatric disorders | Non-systematic Assessment |
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| vein infiltration | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to FSIGT test |
|
| pain in upper left extremity | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |