Clinical trial: Utilizing Protein During Weight Loss to Impact Physical Function and Bone (NCT03819478)

Eligibility criteria:
Subjects are recruited using inclusion and exclusion criteria of the parent trial (UPLIFT;
        NCT03074643).

        Inclusion Criteria:

          -  65-85 years

          -  BMI: 30-45 kg/m2 or BMI 27.0 - <30.0 AND at least one of the following risk factors:

               1. elevated waist circumference (>35 inches in women, >40 inches in men)

               2. diabetes,

               3. hypertension,

               4. dyslipidemia,

               5. or other obesity-related comorbidities: clinically manifest coronary artery
                  disease [e.g., history of myocardial infarction, angina pectoris, coronary artery
                  surgery, coronary artery procedures (e.g., angioplasty) if not within the past
                  year], other atherosclerotic disease [e.g., peripheral arterial disease,
                  abdominal aortic aneurysm, symptomatic carotid artery disease if not within the
                  past year], sleep apnea, or osteoarthritis of the knee or hip.

          -  No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months

          -  SPPB ≥3 to ≤10

          -  No contraindications for safe and optimal participation in exercise training

          -  Approved for participation by Medical Director (Dr. Lyles)

          -  Willing to provide informed consent

          -  Agree to all study procedures and assessments

          -  Willing to consume protein/CHO supplements for up to 18 months

          -  Able to provide own transportation to study visits and intervention sessions

        Exclusion Criteria:

          -  Weight loss (≥5%) in past 6 months

          -  Dependent on cane or walker

          -  Cognitive impairment (MoCA score <22)

          -  Severe arthritis, or other musculoskeletal disorder

          -  Joint replacement or other orthopedic surgery in past year

          -  Uncontrolled resting hypertension (>160/90 mmHg);

          -  Uncontrolled diabetes (HbA1c ≥8.0%)

          -  Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled
             angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled
             endocrine/metabolic disease; neurological or hematological disease; cancer requiring
             treatment in past year, except non-melanoma skin cancers; liver or renal disease; or
             clinically evident edema

          -  Unstable Severe Depression

          -  Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment
             depressions (>3 mm at rest or ≥2 mm with exercise)

          -  Abnormal kidney function (eGFR <30 based on serum creatinine, age, gender, and race)

          -  Anemia (Hb<13 g/dL in men; <12 g/dL in women)

          -  Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men)

          -  Use of any tobacco or nicotine products in the past year

          -  Osteoporosis (T-score < -2.5 on hip or spine scan)

          -  Regular use of growth/steroid hormones, sex steroids or corticosteroids

          -  Osteoporosis medication

          -  Protein supplements (and unwilling to stop using for duration of study)

          -  Weight loss medications or procedures

          -  Current participation in another intervention study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0