Status:
COMPLETED
A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Protein
Diet
Eligibility:
All Genders
45-60 years
Phase:
NA
Brief Summary
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of a...
Detailed Description
The investigators will test the following hypotheses in middle-aged men and women (45-60) years old using a randomized, cross over design. All study objectives will be met concurrently: 1. Meals cont...
Eligibility Criteria
Inclusion
- All races and ethnic backgrounds
- Men and women, age 45-60 years
- Generally healthy (see exclusion criteria)
- Able and willing to provide informed consent
- Ability to speak and read English (\* the study procedures, e.g., muscle biopsy, duration of each acute study, e.g. overnight stay; and multiple dietary questionnaires require sound written and spoken English)
Exclusion
- Sarcopenia (defined by: European Working Group on Sarcopenia in Older People, EWGSOP (44))
- Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
- Peripheral vascular disease
- Pulmonary disease
- History of systemic or pulmonary embolus
- Uncontrolled blood pressure (systolic BP\>170, diastolic BP\>95 mmHg)
- Impaired renal function (creatinine \>1.5 mg/dl)
- Anemia (hematocrit \<33)
- Untreated thyroid disease (abnormal TSH)
- A recent history (\<12 months) of GI bleed
- Diabetes mellitus or other untreated endocrine or metabolic disease
- Electrolyte abnormalities
- Any history of stroke, hypo- or hyper-coagulation disorders
- Recent (3 years) treated cancer other than basal cell carcinoma
- Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months
- Recent (6 months) adherence to a weight-loss or weight-gain diet
- Weight change of 5% or more in previous 6 months
- Body mass index \>30 or excess body fat that compromises muscle biopsy collection
- Body mass index \<20 or recent history (\<12 month) of disordered eating
- Dietary preferences or practices that preclude the consumption of the study meals
- Acute infectious disease or chronic infection
- Alcohol or drug abuse
- Any other condition or event considered exclusionary by study physician
- Pregnancy
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03816579
Start Date
March 26 2019
End Date
January 21 2021
Last Update
April 29 2021
Active Locations (1)
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1
Unversity of Texas Medical Branch
Galveston, Texas, United States, 77555