Sarcopenia Clinical Trial
Official title:
Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement
NCT number | NCT05460351 |
Other study ID # | IRB00025941 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | May 2015 |
Verified date | July 2022 |
Source | Wake Forest University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Able to provide own transportation to study testing visits and intervention - Able to read and write in English - Nondiabetic, i.e. fasting glucose < 126 mg/dl - Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program) - Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months. Exclusion Criteria: - Smoking or use of chewing tobacco - Involved in another intervention research study - Diabetic (type 1 or 2) - Atrophic gastritis - Hypo- or hyperthyroidism - Gout or history of kidney stones - History of hypotension - Premenopausal (women) - Aversion to study-related testing procedures - Allergy/sensitivity/aversion to beetroot beverages or protein supplement - Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement - Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases) - Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism - Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons - Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program - Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole body fat free mass | Mass of fat free tissue | Collected at baseline | |
Primary | Whole body fat mass | Mass of fat tissue | Collected at baseline | |
Primary | Thigh muscle | Volume of thigh muscle | Collected at baseline | |
Primary | Thigh intermuscular fat | Volume of fat in the thigh muscle | Collected at baseline | |
Primary | Thigh subcutaneous fat | Volume of subcutaneous fat in the thigh | Collected at baseline | |
Primary | Visceral fat | Volume of visceral fat | Collected at baseline | |
Primary | Muscle strength | Strength of quadriceps muscle at a speed of 60 degrees per second | Collected at baseline | |
Primary | 400 meter walk | Time to walk 400 meters | Collected at baseline | |
Primary | Stair climb time | Time to ascend and descend 12 stairs | Collected at baseline | |
Primary | Peak oxygen consumption | Peak oxygen consumed at maximal exercise during graded exercise testing | Collected at baseline | |
Primary | Whole body fat free mass | mass of fat free tissue | Collected at 10-weeks | |
Primary | Whole body fat mass | Mass of fat tissue | Collected at 10-weeks | |
Primary | Thigh muscle | Volume of thigh muscle | Collected at 10-weeks | |
Primary | Thigh intermuscular fat | Volume of fat in the thigh muscle | Collected at 10-weeks | |
Primary | Thigh subcutaneous fat | Volume of subcutaneous fat in the thigh | Collected at 10-weeks | |
Primary | Visceral fat | Volume of visceral fat | Collected at 10-weeks | |
Primary | Muscle strength | Strength of quadriceps muscle at a speed of 60 degrees per second | Collected at 10-weeks | |
Primary | 400 meter walk | Time to walk 400 meters | Collected at 10-weeks | |
Primary | Stair climb time | Time to ascend and descend 12 stairs | Collected at 10-weeks |
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