Eating Frequency Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01731522
First received: November 14, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to examine the influence of two Eating Frequency prescriptions, meal (energy intake occurring during three meals per day) and grazing (energy intake occurring every two to three hours per day), on consumption during an ad libitum meal consumed at the end of the day, overall daily energy intake, and ratio of energy intake to energy expenditure. It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.


Condition Intervention
Eating Frequency
Behavioral: EF condition

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Total grams of ad libitum meal consumed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The foods that will be used in this investigation are Tyson Chicken Breast Tenders, Ore-Ida Tater Tots, Birds Eye Steamfresh Pure & Simple green beans, and Sarah Lee Butter Pound Cake. Participants will be provided with ad libitum amounts of the foods, and the foods will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the meal. The weight of the container will also be measured. Total grams of each food consumed during the session will be determined by subtracting pre- and post-consumption weight of food.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EF condition Behavioral: EF condition
Other Name: Grazing, Three meal

Detailed Description:

20 men and women of healthy weight will participate in this study. The complete study design will be a 2 x 2 mixed factorial design, with the between-subject factor of order and a within-subject factor of eating condition (meal or grazing). Depending upon the eating condition, participants will be provided with a morning meal and an afternoon meal (meal) or two small meals and three snacks to be consumed every 2-3 hours (grazing). The types of foods and amount of foods provided to participants will be identical in each condition; the only difference in the conditions is the time spacing during the day when the foods are consumed. The primary dependent variable will be amount, both grams and energy, of food consumed during an ad libitum meal consumed in the evening at the completion of the meal condition, overall daily energy intake, and ratio of daily energy intake to energy expenditure. It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 18 and 35 years
  • body mass index (BMI) between 18.5 and 24.9 kg/m2
  • no history of overweight or obesity
  • unrestrained eater (<12 on Three Factor Eating Questionnaire [TFEQ])
  • regularly participate in at least 150 minutes of moderate-intense physical activity per week over the previous 4 weeks

Exclusion Criteria:

  • currently taking medication that affects appetite or food intake
  • have a medical condition affecting eating or currently following a therapeutic diet
  • are currently participating in a weight loss program and/or taking weight loss medication
  • have gained or lost > 5% of body weight during the past 6 months
  • diagnosed with type 1 or 2 diabetes
  • have had bariatric surgery
  • report disliking foods used in the investigation (scoring a 1 or 2 on a 5-point Likert scale)
  • report having allergies to foods used in the investigation
  • currently smoke
  • report binge eating
  • are graduate students in the Department of Nutrition
  • are pregnant, lactating, < 6 months post-partum.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731522

Locations
United States, Tennessee
The University of Tennessee-Knoxville
Knoxville, Tennessee, United States, 37996-1920
Sponsors and Collaborators
University of Tennessee
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01731522     History of Changes
Other Study ID Numbers: MTRI-Basic EF Study
Study First Received: November 14, 2012
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014