Effect of Dietary Habits on Metabolic Health

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Prediabetes; Meals
• Intervention / Treatment: Behavioral: Meal schedule

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Meals; Meals are eaten early in the wake episode	Behavioral: Meal schedule
Experimental: Late Meals; Meals are eaten late in the wake episode	Behavioral: Meal schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma leptin levels across sleep/wake cycle	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma leptin	Frequent blood samples	During constant routine (Days 7-8)
Change in glucose tolerance	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma glucose levels	Frequent blood samples	During constant routine (Days 7-8)
Change in plasma insulin levels after standardized test meal	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma insulin levels	Frequent blood samples	During constant routine (Days 7-8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol	Core temperature and frequent blood samples	During constant routine (Days 7-8)
Changes circadian rhythm in resting energy expenditure	Indirect calorimetry	During constant routine (Days 7-8)
Change in hunger and appetite, mood, and cognitive performance	Subjective ratings and cognitive tests performed via computer interface	Tests taken throughout the protocol, Days 1-9
Changes in microbiota, gene expression, epigenetic or proteomic markers	Frequent blood samples and saliva samples	Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)
Changes in sleep	Polysomnography	Sleep will be measured during the night after Days 2 and 5
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes	2 fat biopsies, one sample will be taken during each protocol	On Day 5 of each protocol

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 21, 2019
• Study Completion (Actual): April 21, 2019

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Metabolism; Feeding Behavior; Dietary Habits; Circadian
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: R01DK099512 (U.S. NIH Grant/Contract)