The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
The purpose of this project is to determine if protein is less likely to create positive
 energy balance when added to the diet compared to carbohydrate. To do this, the investigators
 will take detailed measurements of participant's baseline metabolic rate to understand their
 energy requirements. Then, the investigators will feed participants all their meals for two
 weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding
 periods, participants will consume a shake made of egg protein that is ~20% of their energy
 requirements. During the other week, participants will consume a shake made of carbohydrate
 that is ~20% of their energy requirements. Participants will drink the assigned shake at the
 beginning of each of their daily three meals, and then they will be offered a 'regular' meal
 of unlimited quantity. Participants will not know that the investigators are measuring the
 food consumed after drinking the shake. Participants will drink the protein shake for the
 first week and carb-based shake for the second week, and vice versa-- depending on the
 randomization order. To account for energy expenditure, participants will wear an activity
 monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy
 expenditure, will be our main outcome for each treatment. However, because participants may
 change their behavior if made aware of the true research question, the investigators will
 tell participants that the purpose of the study is to see how low fiber and high fiber shakes
 affect mood. The hypothesis is that during the week when participants consume the protein
 shake, they will remain in energy balance, but during the week of carbohydrate shake
 consumption, participants will have positive energy balance.
Inclusion Criteria:

 -  BMI ≥20, and ≤30 kg/m2

 -  Moderately active or sedentary (Physical Activity Level <2.0)

 Exclusion Criteria:

 -  Any food allergy.

 -  Religious affiliations that include specific food guidelines.

 -  Participation in any weight-reduction program, weight-loss diet, or other special diet
 within the previous 3 months.

 -  Weight loss or gain of >5% of body weight in the past 6 months for any reason except
 post-partum weight loss.

 -  Currently taking medication that suppresses or stimulates appetite or that affects
 body weight, including oral anti-diabetic medications.

 -  History of prior surgical procedure for weight control.

 -  Anyone currently taking statins.

 -  Claustrophobia

 -  Current smoker or quit smoking less than 6 months prior.

 -  Any major disease, including:

 -  Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma
 skin cancer).

 -  Active or chronic infections, including self-reported HIV positivity and active
 tuberculosis. -Active cardiovascular disease or event including hospitalization or
 therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass,
 percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart
 Association Functional Class >2 with respect to congestive heart failure; stroke or
 transient ischemic attack in the past 6 months.

 -  Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any
 episode of alcoholic hepatitis or alcoholic pancreatitis within past year,
 inflammatory bowel disease requiring treatment in the past year, recent or significant
 abdominal surgery (e.g., gastrectomy).

 -  Active renal disease.

 -  Lung disease: chronic obstructive airway disease requiring use of oxygen.

 -  Diagnosed diabetes (type 1 or 2).

 -  Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar
 disorder) that, in opinion of the investigators, would impede conduct of the trial or
 completion of procedures.

 -  A score on the Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) that
 exceeds the 90th percentile.

 -  History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score
 >20.

 -  Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling
 to give informed consent; unable to communicate with the pertinent clinic staff;
 another household member is a participant or staff member in the trial; current or
 anticipated participation in another intervention research project that would
 interfere with the intervention offered in the trial; likely to move away from
 participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.

 -  Currently taking antidepressant, steroid, or thyroid medication, unless dosage has
 been stable for at least 6 months.

 -  A recent or ongoing problem with drug abuse or addiction.

 -  Excessive alcohol intake, either acute or chronic, defined as any one of the
 following: 1) average consumption of 3 or more alcohol containing beverages daily; 2)
 consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12
 months; or 3) other evidence available to clinic staff.

 -  Pregnancy and childbearing: currently pregnant or less than 3 months post partum;
 currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated
 during study; unwilling to report possible or confirmed pregnancies promptly during
 the course of the trial; unwilling to take adequate contraceptive measures if
 potentially fertile.

 -  Any other conditions which, in opinion of the investigators, would adversely affect
 the conduct of the trial.