The Role of Protein in Regulating Ad Libitum Energy Intake in Humans

Energy Balance Clinical Trial

Official title:

The Role of Protein in Regulating Ad Libitum Energy Intake in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613065
• Other study ID #: F141121006
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: August 18, 2016
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Energy Balance

Intervention

Dietary Supplement:
• Consumption of NOW Foods eggwhite protein shake
Consumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
• Consumption of NOW Foods maltodextrin shake
Consumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Balance measured as participant energy intake (food weight before and after meals) minus energy expenditure (accelerometer)	Feeding periods are separated by two weeks.	10 days	No