Positive Energy I Through Overfeeding

Behavioral Response to Short-term (Two-day) Positive Energy Balance Through Overfeeding (ENERGY I)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Diet A; Other: Diet B; Other: Diet C

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Intake	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.	4 days following the 2 day overfeeding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Expenditure	Armbands were worn by participants throughout the protocol to quantify changes in activity levels and energy expenditure to positive energy balance.	4 days following 2 days of overfeeding

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Publications and helpful links

General Publications

• Apolzan JW, Bray GA, Hamilton MT, Zderic TW, Han H, Champagne CM, Shepard D, Martin CK. Short-term overeating results in incomplete energy intake compensation regardless of energy density or macronutrient composition. Obesity (Silver Spring). 2014 Jan;22(1):119-30. doi: 10.1002/oby.20587. Epub 2013 Sep 10.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 30, 2012

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Satiety; Appetite
• Other Study ID Numbers: PBRC 10017