The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 30 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | November 2016 |
| Contact: | Madeline M Jeansonne, MPH |
| Email: | mmjean@uab.edu |
| Phone: | 205-975-9273 |
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.
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.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-975-9273
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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