Effect of Dietary Habits on Metabolic Health

Obesity Clinical Trial

Official title:

Effect of Dietary Habits on Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298790
• Other study ID #: R01DK099512
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 21, 2019

Study information

• Verified date: November 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 21, 2019
• Est. primary completion date: April 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Meals
• Obesity
• Overweight
• Prediabetes

Intervention

Behavioral:
• Meal schedule

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma leptin levels across sleep/wake cycle	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Primary	Change in circadian profile of plasma leptin	Frequent blood samples	During constant routine (Days 7-8)
Primary	Change in glucose tolerance	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Primary	Change in circadian profile of plasma glucose levels	Frequent blood samples	During constant routine (Days 7-8)
Primary	Change in plasma insulin levels after standardized test meal	Frequent blood samples	During standardized meals scheduled on Days 3 and 6
Primary	Change in circadian profile of plasma insulin levels	Frequent blood samples	During constant routine (Days 7-8)
Secondary	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)
Secondary	Changes circadian rhythm in resting energy expenditure	Indirect calorimetry	During constant routine (Days 7-8)
Secondary	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
Secondary	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)
Secondary	Changes in sleep	Polysomnography	Sleep will be measured during the night after Days 2 and 5
Secondary	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