Clinical trial NCT02298790: Effect of Dietary Habits on Metabolic Health
Official title: Effect of Dietary Habits on Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Prediabetes
Meals
Keywords: Dietary Habits
Circadian
Metabolism
Feeding Behavior
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-11-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.

Detailed description: More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 37.9 kgm-2
* Adults with regular sleep-wake timing
* Non-smokers
* Completion of medical and psychological screening tests
* Able to spend 14 consecutive days in the sleep laboratory

Exclusion Criteria:

* BMI \< 25 or \> 37.9 kgm-2
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Donating blood within past 8 weeks
* Worked night or rotating shift work within past 3 years
* Hearing impairment
* Drug or alcohol dependency

Primary outcomes:
measure: Change in plasma leptin levels across sleep/wake cycle
timeFrame: During standardized meals scheduled on Days 3 and 6
measure: Change in circadian profile of plasma leptin
timeFrame: During constant routine (Days 7-8)
measure: Change in glucose tolerance
timeFrame: During standardized meals scheduled on Days 3 and 6
measure: Change in circadian profile of plasma glucose levels
timeFrame: During constant routine (Days 7-8)
measure: Change in plasma insulin levels after standardized test meal
timeFrame: During standardized meals scheduled on Days 3 and 6
measure: Change in circadian profile of plasma insulin levels
timeFrame: During constant routine (Days 7-8)
Secondary outcomes:
measure: Change in circadian phase markers, such as from core body temperature, melatonin, cortisol
timeFrame: During constant routine (Days 7-8)
measure: Changes circadian rhythm in resting energy expenditure
timeFrame: During constant routine (Days 7-8)
measure: Change in hunger and appetite, mood, and cognitive performance
timeFrame: Tests taken throughout the protocol, Days 1-9
measure: Changes in microbiota, gene expression, epigenetic or proteomic markers
timeFrame: Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)
measure: Changes in sleep
timeFrame: Sleep will be measured during the night after Days 2 and 5
measure: Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes
timeFrame: On Day 5 of each protocol
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank AJL Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vujovic N, Piron MJ, Qian J, Chellappa SL, Nedeltcheva A, Barr D, Heng SW, Kerlin K, Srivastav S, Wang W, Shoji B, Garaulet M, Brady MJ, Scheer FAJL. Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Cell Metab. 2022 Oct 4;34(10):1486-1498.e7. doi: 10.1016/j.cmet.2022.09.007.