Effect of Dietary Habits on Metabolic Health

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02298790
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 53.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity; Prediabetes; Meals	Behavioral: Meal schedule	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effect of Dietary Habits on Metabolic Health
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Apr 21, 2019
• Actual Study Completion Date: Apr 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in plasma leptin levels across sleep/wake cycle [During standardized meals scheduled on Days 3 and 6]

   Frequent blood samples

2. Change in circadian profile of plasma leptin [During constant routine (Days 7-8)]

   Frequent blood samples

3. Change in glucose tolerance [During standardized meals scheduled on Days 3 and 6]

   Frequent blood samples

4. Change in circadian profile of plasma glucose levels [During constant routine (Days 7-8)]

   Frequent blood samples

5. Change in plasma insulin levels after standardized test meal [During standardized meals scheduled on Days 3 and 6]

   Frequent blood samples

6. Change in circadian profile of plasma insulin levels [During constant routine (Days 7-8)]

   Frequent blood samples

Secondary Outcome Measures

1. Change in circadian phase markers, such as from core body temperature, melatonin, cortisol [During constant routine (Days 7-8)]

   Core temperature and frequent blood samples

2. Changes circadian rhythm in resting energy expenditure [During constant routine (Days 7-8)]

   Indirect calorimetry

3. Change in hunger and appetite, mood, and cognitive performance [Tests taken throughout the protocol, Days 1-9]

   Subjective ratings and cognitive tests performed via computer interface

4. Changes in microbiota, gene expression, epigenetic or proteomic markers [Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)]

   Frequent blood samples and saliva samples

5. Changes in sleep [Sleep will be measured during the night after Days 2 and 5]

   Polysomnography

6. Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes [On Day 5 of each protocol]

   2 fat biopsies, one sample will be taken during each protocol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank AJL Scheer, PhD, Frank AJL Scheer, PhD, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02298790
• Other Study ID Numbers: R01DK099512
• First Posted: Nov 24, 2014
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Frank AJL Scheer, PhD, Frank AJL Scheer, PhD, Brigham and Women's Hospital: Dietary Habits; Circadian; Metabolism; Feeding Behavior
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Nov 4, 2020