NCT02298790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.5 years

First QC Date

November 20, 2014

Last Update Submit

November 2, 2020

Conditions

OverweightObesityPrediabetesMeals

Keywords

Dietary HabitsCircadianMetabolismFeeding Behavior

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • Change in circadian phase markers, such as from core body temperature, melatonin, cortisol

    During constant routine (Days 7-8)

  • Changes circadian rhythm in resting energy expenditure

    During constant routine (Days 7-8)

  • Change in hunger and appetite, mood, and cognitive performance

    Tests taken throughout the protocol, Days 1-9

  • Changes in microbiota, gene expression, epigenetic or proteomic markers

    Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)

  • Changes in sleep

    Sleep will be measured during the night after Days 2 and 5

  • +1 more secondary outcomes

Study Arms (2)

Early Meals

EXPERIMENTAL

Meals are eaten early in the wake episode

Behavioral: Meal schedule

Late Meals

EXPERIMENTAL

Meals are eaten late in the wake episode

Behavioral: Meal schedule

Interventions

Meal scheduleBEHAVIORAL
Early MealsLate Meals

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 36198293DERIVED

MeSH Terms

Conditions

OverweightObesityPrediabetic StateFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Officials

  • Frank AJL Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Frank AJL Scheer, PhD

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

November 1, 2014

Primary Completion

April 21, 2019

Study Completion

April 21, 2019

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(1)