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Positive Energy I Through Overfeeding

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01653145
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
18
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity.

It is hypothesized that: 1) food intake will not differ significantly after 2 days of positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are low in energy density, and 2) food intake will be higher after a positive energy balance induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet A
  • Other: Diet B
  • Other: Diet C
 N/A

Detailed Description

The purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity. During this study, we will induce a positive energy balance for two days by increasing food intake to 140% of baseline energy requirements and keeping energy expenditure constant. The following three diets, which vary in dietary fat and energy density (kcal/g), will be used to induce the positive energy balance in a within subjects or cross over design: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. Food intake and activity will be measured for 4 days after each diet to quantify the response to positive energy balance and manipulation of dietary fat and energy density.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Official Title:
Behavioral Response to Short-term (Two-day) Positive Energy Balance Through Overfeeding (ENERGY I)
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diet A

Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

Other: Diet A
Dietary
Other Names:
  • Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet B
    Dietary
    Other Names:
  • High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet C
    Dietary
    Other Names:
  • High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein

    		•
    Active Comparator: Diet B

    High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    Other: Diet A
    Dietary
    Other Names:
  • Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet B
    Dietary
    Other Names:
  • High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet C
    Dietary
    Other Names:
  • High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein

    		•
    Active Comparator: Diet C

    High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein

    Other: Diet A
    Dietary
    Other Names:
  • Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet B
    Dietary
    Other Names:
  • High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein

    • Other: Diet C
    Dietary
    Other Names:
  • High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Energy Intake [4 days following the 2 day overfeeding]

      Food intake will be measured for 4 days after positive energy balance by directly weighing foods before and after ad libitum lunch and dinner. All food intake testes will occur while the participant resides in the inpatient unit.

    Secondary Outcome Measures

    1. Energy Expenditure [4 days following 2 days of overfeeding]

      Armbands were worn by participants throughout the protocol to quantify changes in activity levels and energy expenditure to positive energy balance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.

    • Your body mass index (BMI) is between 20 and 40 kg/m², inclusive.

    • For females, if you have regular menstrual periods, with no less than 28 day cycles. Monophasic birth control pills, copper IUD, Ortho Evra patch, NuvaRing or complete hysterectomy are also acceptable.

    Exclusion Criteria:

    • You have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.

    • You have irregular menstrual cycles, had a partial hysterectomy (still maintain ovaries), or use an IUD not made of copper.

    • You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).

    • You use a birth control pill that isn't monophasic or you receive Depro-Provera injections.

    • You have barriers to completing the study, such as work or family commitments.

    • You have symptoms of depression or excessive dietary restraint.

    • You use tobacco products.

    • You exercise more than 1 hour per day, 5 or more days per week.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01653145
    Other Study ID Numbers:
    • PBRC 10017
    First Posted:
    Jul 30, 2012
    Last Update Posted:
    Jan 18, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
    Appetite
    Satiety

    Study Results

    No Results Posted as of Jan 18, 2016