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Timing of Eating Study Among Obese Adults

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ClinicalTrials.gov Identifier: NCT03354169
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kelly Allison, University of Pennsylvania

Brief Summary:
The randomized, cross-over design study is designed to determine how timing of eating affects weight, adiposity, energy metabolism, and gene expression. Obese participants will be provided isocaloric meals and snacks to be consumed in one of two prescribed eating conditions -- daytime eating and delayed eating.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Eating Condition Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized within subjects, cross-over design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Daytime vs. Delayed Eating Among Obese Adults
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
Experimental: Daytime Eating Condition
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
Behavioral: Eating Condition
Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.

Experimental: Delayed Eating Condition
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
Behavioral: Eating Condition
Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.




Primary Outcome Measures :
  1. body mass (weight) [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    changes in body mass, as measured by a calibrated digital scale, will be explored.

  2. adiposity [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    changes in measures of body fat, as measured by a DEXA scan, will be explored.

  3. energy homeostasis outcomes [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    Changes in resting energy expenditure values will be explored.


Secondary Outcome Measures :
  1. circadian ghrelin rhythms [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    differences in circadian ghrelin rhythms will be explored.

  2. circadian leptin rhythms [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    differences in circadian leptin rhythms will be explored.

  3. gene expression profiles [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    differences in the phase and cycling of gene expression profiles will be explored.

  4. insulin sensitivity [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks). ]
    changes in insulin sensitivity will be explored.

  5. free fatty acid dynamics [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks) ]
    changes in free fatty acid dynamics will be explored.

  6. adipose tissue gene expression [ Time Frame: pre-post changes between the daytime and delayed eating conditions (8 weeks) ]
    changes in adipose tissue gene expression will be explored.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 21-50
  • BMI of 30-50 kg/m2
  • stable weight (±10 lb) over the previous 6 months
  • women must be pre-menopausal with regular menstrual cycles

Exclusion Criteria:

  • unstable, serious medical conditions
  • use of medicine linked to weight gain/loss
  • metabolic syndrome
  • cardiac conditions
  • cancer
  • diabetes
  • autoimmune disease
  • use of illicit drugs, melatonin, diuretics or hypnotics
  • involved in a current weight loss program
  • presence of a sleep disorder (determined by surveys and actigraphy)
  • those who work shift work
  • those with extreme chronotypes
  • habitual waking outside of 0600h-0930h
  • habitual bedtime <2200h or >2400h
  • sleep duration of <6.5 or >8.5 h/night.
  • psychiatric exclusions will be: depression (Patient Health Questionnaire-9 score ≥9), lifetime bipolar disorder, psychosis, or eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the MINI International Neuropsychiatric Interview.
  • structured exercise >3 d/wk, for >30 min measured by exercise logs and actigraphy; normal activity levels are required during the study (±30 min/wk of baseline level).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354169


Contacts
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Contact: Elizabeth Jones, BS 215-573-5502 ejonesa@pennmedicine.upenn.edu
Contact: Kelly Allison, PhD 215-898-2823 kca@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kelly Allison, PhD    215-898-2823    kca@pennmedicine.upenn.edu   
Principal Investigator: Kelly Allison, PhD         
Principal Investigator: Namni Goel, PhD         
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: Kelly Allison, Director, Center for Weight and Eating Disorders, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03354169     History of Changes
Other Study ID Numbers: 828317
R01DK117488-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kelly Allison, University of Pennsylvania:
Metabolism
Eating
Circadian Rhythms