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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source Wake Forest University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
BRJ+Nitrate
Participants in this group drank a 70 mL bottle of Beet It Sport drink with nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program
Control
Participants in this group drank a 70 mL bottle of Beet It Sport drink without nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Outcome

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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