Positive Energy I Through Overfeeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01653145
First received: July 26, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention
Obesity
Other: Diet A
Other: Diet B
Other: Diet C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Behavioral Response to Short-term (Two-day) Positive Energy Balance Through Overfeeding (ENERGY I)

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Energy Intake [ Time Frame: 4 days following the 2 day overfeeding ] [ Designated as safety issue: No ]
    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:
  • Energy Expenditure [ Time Frame: 4 days following 2 days of overfeeding ] [ Designated as safety issue: No ]
    Armbands were worn by participants throughout the protocol to quantify changes in activity levels and energy expenditure to positive energy balance.


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet B
Dietary
Other Name: High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet C
Dietary
Other Name: 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 Name: Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet B
Dietary
Other Name: High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet C
Dietary
Other Name: 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 Name: Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet B
Dietary
Other Name: High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein
Other: Diet C
Dietary
Other Name: High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01653145

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01653145     History of Changes
Other Study ID Numbers: PBRC10017
Study First Received: July 26, 2012
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Appetite
Satiety

ClinicalTrials.gov processed this record on October 30, 2014