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CompletedNCT01653145Updated Jan 18, 2016

Positive Energy I Through Overfeeding

An interventional study of Diet A and Diet B in Obesity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-18.

Sponsored by Pennington Biomedical Research Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Appetite
  • Satiety
03

In context

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Diet A

    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

  • Active comparator
    Diet B

    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

  • Active comparator
    Diet C

    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

  • OtherDiet A

    Dietary

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

  • OtherDiet B

    Dietary

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

  • OtherDiet C

    Dietary

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

06

What researchers measure

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.

    Time frame: 4 days following the 2 day overfeeding

Secondary outcomes

  1. Energy Expenditure

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

    Time frame: 4 days following 2 days of overfeeding

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

References and documents

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. PubMed 23913807 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01653145
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Corby K. Martin (Principal Investigator, Pennington Biomedical Research Center) — Principal investigator
First posted
Jul 30, 2012
Start date
Jul 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jan 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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