Clinical trial NCT05460351: Beetroot Juice Resistance Training Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Old Age; Atrophy
Lead sponsor: Wake Forest University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed. Both groups will undergo resistance exercise training and consume a protein supplement
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Whole body fat free mass
timeFrame: Collected at baseline
measure: Whole body fat mass
timeFrame: Collected at baseline
measure: Thigh muscle
timeFrame: Collected at baseline
measure: Thigh intermuscular fat
timeFrame: Collected at baseline
measure: Thigh subcutaneous fat
timeFrame: Collected at baseline
measure: Visceral fat
timeFrame: Collected at baseline
measure: Muscle strength
timeFrame: Collected at baseline
measure: 400 meter walk
timeFrame: Collected at baseline
measure: Stair climb time
timeFrame: Collected at baseline
measure: Peak oxygen consumption
timeFrame: Collected at baseline
measure: Whole body fat free mass
timeFrame: Collected at 10-weeks
measure: Whole body fat mass
timeFrame: Collected at 10-weeks
measure: Thigh muscle
timeFrame: Collected at 10-weeks
measure: Thigh intermuscular fat
timeFrame: Collected at 10-weeks
measure: Thigh subcutaneous fat
timeFrame: Collected at 10-weeks
measure: Visceral fat
timeFrame: Collected at 10-weeks
measure: Muscle strength
timeFrame: Collected at 10-weeks
measure: 400 meter walk
timeFrame: Collected at 10-weeks
measure: Stair climb time
timeFrame: Collected at 10-weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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