Dinner Time for Obesity and Prediabetes
Overview
- Phase
- Not Applicable
- Intervention
- Late Dinner
- Conditions
- PreDiabetes
- Sponsor
- Johns Hopkins University
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- 24-hour total fat oxidation
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
Detailed Description
This is a randomized, cross-over study that examines the metabolic impact of early vs late dinner, as defined by proximity of food intake to an individual's biological night as determined by dim light melatonin onset (DLMO) in normal-weight, healthy adult volunteers and in adults with obesity and prediabetes. Each participant will first undergo circadian phenotyping at the Johns Hopkins Bayview Clinical Research Unit (Baltimore, Maryland), with assessment of DLMO and core body temperature profile, as well as wrist actigraphy. Thereafter, participants will be crossover randomized to (1) a 24-hour metabolic chamber protocol where dinner is eaten 3 hours before DLMO (early dinner), or (2) a 24-hour metabolic chamber protocol where dinner is 1 hour eaten after DLMO (late dinner), both to be performed at the NIH Metabolic Clinical Research Unit (Bethesda, Maryland). The timing and nutritional contents of all meals, as well as sleep timing and duration, will be held constant. Oral \[2H31\] palmitate will be given with each dinner condition to quantify dietary fat oxidation. The 2 dinner conditions will occur in random order, with a 3- to 4-week washout period. The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants.
- •Inclusion Criteria:
- •For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
- •For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
- •All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.
Exclusion Criteria
- •Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
- •Night shift work
- •Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00
- •Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
- •Active smoking
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Diabetes (type 1 or 2) or on any diabetes medications besides metformin
- •Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
- •Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort
- •Hemoglobin \< 10 g/dL
Arms & Interventions
Early Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Intervention: Late Dinner
Early Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Intervention: Early Dinner
Early Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Intervention: Early Dinner tracer
Early Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Intervention: Late Dinner tracer
Late Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Intervention: Early Dinner
Late Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Intervention: Late Dinner
Late Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Intervention: Early Dinner tracer
Late Dinner First
Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Intervention: Late Dinner tracer
Outcomes
Primary Outcomes
24-hour total fat oxidation
Time Frame: baseline, 4 weeks
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
Secondary Outcomes
- 14-hour post-dinner cumulative dietary fat oxidation(baseline, 4 weeks)
- 4-hour post-prandial area-under-the-curve insulin levels(baseline, 4 weeks)
- 4-hour post-prandial area-under-the-curve (AUC) glucose levels(baseline, 4 weeks)