Positive Energy I Through Overfeeding

NCT01653145 | Completed

• 1 other identifier: PBRC 10017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Appetite; Satiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Energy Expenditure

  4 days following 2 days of overfeeding

Study Arms (3)

Diet A

ACTIVE COMPARATOR

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

Other: Diet A; Other: Diet B; Other: Diet C

Diet B

ACTIVE COMPARATOR

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

Other: Diet A; Other: Diet B; Other: Diet C

Diet C

ACTIVE COMPARATOR

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

Other: Diet A; Other: Diet B; Other: Diet C

Interventions

Diet A OTHER

Dietary

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

Diet A; Diet B; Diet C

Diet B OTHER

Dietary

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

Diet A; Diet B; Diet C

Diet C OTHER

Dietary

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

Diet A; Diet B; Diet C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 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.

  PMID: 23913807 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Carbohydrates; Proteins

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)