Protein Supplementation and Fat Mass Loss

Increase intake of dietary protein has been shown to have a role in weight loss and weight
management since it affects satiety, thermogenesis, energy efficiency, and body composition.
However, the effects of long-term protein supplementation on body fat mass in free living
individuals with overweight and obesity are not known. This knowledge is important because
people are more likely to take a protein supplement and expect to achieve fat loss without
any other life style modification. Our research question is, whether consumption of whey
protein supplements prior to main meals will reduce body weight and body fat without other
intentional behavioral changes. We hypothesize that, addition of a 30g protein drink (100%
whey isolate) 1 hour before lunch and dinner would promote negative energy balance, leading
to body fat reduction in free living individuals with overweight and obesity in the absence
of any other lifestyle changes. Our specific aims are: (1) To determine the impact of
long-term protein supplementation on energy expenditure and body composition; (2) To
determine the impact of long-term protein supplementation in free living condition on satiety
and hunger; and (3) To determine the impact of long-term protein supplementation on physical
activity and muscle strength. To test our hypothesis, we will conduct a 12-week, two parallel
group randomized controlled trial with an additional baseline week. The intervention group
will be advised to consume 30g whey protein shake 1 hour before lunch and before dinner for
12 weeks while the control group will not consume protein shakes. Both groups will continue
usual dietary habits and physical activity. We will measure food intake using 3-day dietary
records pre-intervention, and during intervention at week 7, and 12. Physical activity will
be monitored using a hip worn accelerometer pre-intervention and during 6th week of
intervention. Measurements taken pre-intervention, at the end of 6th week and at the end of
12th week include body weight, body composition using dual energy x-ray absorptiometry and
bioelectrical impedance analysis. Resting metabolic rate will be measured using indirect
calorimetry pre- and post-intervention. Between-meal satiety and hunger will be measured
using 100 mm Visual Analog Scales at 6am, 11am, I hour after lunch, 6pm, 1 hour after dinner
at baseline, day 14th, 43th and 83rd.

Inclusion Criteria:

- Ages 19-55 years

- Body mass index more than or equal to 23 kg/m2 for Asians and more than or equal to 25
kg/m2 for other ethnic groups up to 40 kg/m2

- Individuals who are able to speak, read and write in English

Exclusion Criteria:

- Lactose intolerance

- Food allergies to milk products

- 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 or planning to enroll in those within next 3 months

- History of prior surgical procedure for weight control or planning to have one within
next 3 months

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

- 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).

- On medication that may not be absorbed while on whey protein supplements:
Levodopa, alendronate and Albendazole

- Diagnosed hypertension or resting blood pressure more than 140/90

- 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.

- Zung Self-Rating Depression Scale score is >42 and Eating Attitudes Test score to
ensure that our participants do not have symptoms of depression

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

- Conditions or behaviors likely to affect 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.

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

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

- Anyone currently taking statins

- 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.

- Not willing to stop taking protein supplements for the next 3 months, if selected for
the control

- Engaged in aerobic physical activity (brisk walking, jogging, and running) for more
than 30 minutes per day for 5 times per week or performing any resistance training

- Ratings for the supplement taste is 5 or more on a Likert Scale from 1= "Dislike
extremely" to 9= "Like extremely" after tasting the protein shake

- Any other conditions which in opinion of the investigators that would adversely affect
the conduct of the trial will also be excluded