Effect of Late Dinner on Nocturnal Metabolism
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ClinicalTrials.gov Identifier: NCT03525717 |
Recruitment Status :
Completed
First Posted : May 16, 2018
Last Update Posted : December 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Dietary Supplement: Routine Dinner Dietary Supplement: Late dinner | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Routine vs Late Dinner on Nocturnal Metabolism and Fat Oxidation |
Actual Study Start Date : | May 8, 2018 |
Actual Primary Completion Date : | January 1, 2020 |
Actual Study Completion Date : | January 1, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Routine Dinner
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at "routine" dinner time (18:00) followed by a sleep study (23:00). Timing of dinner is the sole intervention distinguishing this arm from late dinner. This arm will cross-over to late dinner in random order.
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Dietary Supplement: Routine Dinner
Participants will be served dinner at a routine time (18:00), along with with a stable isotope of palmitate to measure fat oxidation overnight. Dietary Supplement: Late dinner Participants will be served dinner at a late time (22:00), along with with a stable isotope of palmitate to measure fat oxidation overnight. |
Experimental: Late Dinner
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a "late" dinner time (22:00) followed by a sleep study (23:00). Timing of dinner is the sole intervention distinguishing this arm from routine dinner. This arm will cross-over to routine dinner in random order.
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Dietary Supplement: Routine Dinner
Participants will be served dinner at a routine time (18:00), along with with a stable isotope of palmitate to measure fat oxidation overnight. Dietary Supplement: Late dinner Participants will be served dinner at a late time (22:00), along with with a stable isotope of palmitate to measure fat oxidation overnight. |
- Free Fatty Acids (FFA, mmol/L) [ Time Frame: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time ]Serial blood samples taken during visit, 20 time points per visit, 2 nights
- Glucose (mg/dl) [ Time Frame: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time ]Serial blood samples taken during visit, 20 time points per visit, 2 nights
- Insulin (mcU/ml) [ Time Frame: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time ]Serial blood samples taken during visit, 20 time points per visit, 2 nights
- Triglycerides (mg/dl) [ Time Frame: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time ]Serial blood samples taken during visit, 20 time points per visit, 2 nights
- Oxidation of palmitate (mass spectroscopy) [ Time Frame: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time ]Serial blood samples taken during visit, 20 time points per visit, 2 nights
- Polysomnography [ Time Frame: 1 sleep study per visit, 4 weeks apart ]Overnight sleep study
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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria for enrollment and additional information are available at:
https://dinnertimestudy.net/
Inclusion Criteria:
- Healthy male and female adult volunteers, age 18-30.
- Accustomed to a bedtime between 10:00 PM and 1:00 AM.
Exclusion Criteria:
- Sleep disorder including insomnia, sleep apnea, circadian rhythm disorder, restless leg syndrome, narcolepsy, shift work sleep disorder
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bed time.
- Chronic use of sedative hypnotics, anxiolytics, opiates
- Use of medications that can affect circadian rhythm (beta blockers, melatonin)
- Active smoking (may interfere with metabolism and CRU activities)
- Diabetes (type 1 or 2)
- Obesity (BMI≥30)
- Pregnant or lactating female (pregnancy test will be required)
- Professional or collegiate athlete
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525717
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Jonathan Jun, MD | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT03525717 |
Other Study ID Numbers: |
IRB00156120 |
First Posted: | May 16, 2018 Key Record Dates |
Last Update Posted: | December 2, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We will provide raw data (without identifying information) to journals or other researchers upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | The data will be provided upon request within 1 year after publication and will be available to indefinitely. |
Access Criteria: | The PI will accept requests from other researchers who are examining pertinent outcomes. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
healthy volunteers metabolism fat oxidation obesity sleep |