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Completed

NCT Number: NCT01653145

Positive Energy I Through Overfeeding

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet A

Other

Dietary

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

Diet B

Other

Dietary

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

Diet C

Other

Dietary

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

Primary outcomes

  1. Energy Intake

    Time frame: 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 outcomes

  1. Energy Expenditure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2012
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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