Obesity Clinical Trial
Official title:
Effects of Protein Supplementation on Fat Mass Loss in Free Living Individuals With Overweight and Obesity - A Randomized Controlled Trial
Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Group differences in change in body fat mass | Fat mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner (GE Medical Systems) and the Imp SFB7 BIS (ImpediMed Ltd, Australia) at baseline, and at end of the treatment period. The outcome to be compared between groups will be change in percent fat mass from baseline to post treatment. | Baseline, end of 6th week and end of 12th week of intervention period | |
Secondary | Group differences in change in physical activity energy expenditure | Participants will be instructed to wear a tri-axial accelerometer (AntiGraph GT3X+, Pensacola, FL) on their right hip during waking hours for 7 days. Accelerations will be summed over 1 minute epochs and 60 minutes will be used to determine non-wear time. Using the Freedson VM3 Combination algorithm (42) in Actilife v6.13.3, accelerometer data will be processed to yield estimates of daily and weekly PAEE for each treatment period. Participants will be asked to wear an accelerometer and keep a log of their daily activities that include planned exercise for seven days during week 3 of the protocol. | Baseline and week 7 of the intervention period | |
Secondary | Group differences in changes in meal satiety and hunger | Satiety and hunger will be measured using 100 mm Visual Analog Scales anchored by "not at all" to "extremely" in response to questions about hunger, fullness, desire to eat, and ability to eat more just before consuming before and after meals. Participants will be asked to fill out these questionnaires at 6am, 11am, I hour after lunch, 6pm, 1 hour after dinner. | Baseline, day 14, 43 and 83 of intervention period | |
Secondary | Group differences in change in resting Metabolic Rate | Resting metabolic rate will be measured by indirect calorimetry using the Cosmed's FitMateTM (COSMED, Italy) metabolic system using a canopy dilution set-up. | Baseline, and at end 12 weeks of intervention period | |
Secondary | Group differences in changes in food intake | Food intake will be studied over 3 days (one weekend and 2 weekdays) Dietary data will be used to calculate energy intake and macronutrient distribution of participant diets using the USDA nutrient database. | Baseline, at week 7, and at week 12 of intervention period | |
Secondary | Group differences in changes in grip strength | Grip strength will be measured using the Lafayette Hand Grip Dynamometer | Baseline and after the 6th and 12th week of intervention. | |
Secondary | Group differences in change in lean mass | Lean mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner | Baseline and after 6th and 12th week of intervention |
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