Protein Supplementation and Fat Mass Loss

Status unconfirmed · Not applicable

Conditions studied: Obesity

In brief

Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition.

Key facts

Study ID

NCT03678701

Run by

Texas Tech University

People needed

60

Starts

2018-10-01

Expected to finish

2020-02-28

Last updated by the study team

2019-11-26

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Texas Tech University — Lubbock, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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