- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460351
Beetroot Juice Resistance Training Older Adults
July 12, 2022 updated by: Gary Miller, Wake Forest University
Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: BRJ+Nitrate
This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 380 mg of nitrate plus a 15 dose of whey protein after each exercise session.
|
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
|
|
PLACEBO_COMPARATOR: Control
This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 0 mg of nitrate plus a 15 dose of whey protein after each exercise session.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole body fat free mass
Time Frame: Collected at baseline
|
Mass of fat free tissue
|
Collected at baseline
|
|
Whole body fat mass
Time Frame: Collected at baseline
|
Mass of fat tissue
|
Collected at baseline
|
|
Thigh muscle
Time Frame: Collected at baseline
|
Volume of thigh muscle
|
Collected at baseline
|
|
Thigh intermuscular fat
Time Frame: Collected at baseline
|
Volume of fat in the thigh muscle
|
Collected at baseline
|
|
Thigh subcutaneous fat
Time Frame: Collected at baseline
|
Volume of subcutaneous fat in the thigh
|
Collected at baseline
|
|
Visceral fat
Time Frame: Collected at baseline
|
Volume of visceral fat
|
Collected at baseline
|
|
Muscle strength
Time Frame: Collected at baseline
|
Strength of quadriceps muscle at a speed of 60 degrees per second
|
Collected at baseline
|
|
400 meter walk
Time Frame: Collected at baseline
|
Time to walk 400 meters
|
Collected at baseline
|
|
Stair climb time
Time Frame: Collected at baseline
|
Time to ascend and descend 12 stairs
|
Collected at baseline
|
|
Peak oxygen consumption
Time Frame: Collected at baseline
|
Peak oxygen consumed at maximal exercise during graded exercise testing
|
Collected at baseline
|
|
Whole body fat free mass
Time Frame: Collected at 10-weeks
|
mass of fat free tissue
|
Collected at 10-weeks
|
|
Whole body fat mass
Time Frame: Collected at 10-weeks
|
Mass of fat tissue
|
Collected at 10-weeks
|
|
Thigh muscle
Time Frame: Collected at 10-weeks
|
Volume of thigh muscle
|
Collected at 10-weeks
|
|
Thigh intermuscular fat
Time Frame: Collected at 10-weeks
|
Volume of fat in the thigh muscle
|
Collected at 10-weeks
|
|
Thigh subcutaneous fat
Time Frame: Collected at 10-weeks
|
Volume of subcutaneous fat in the thigh
|
Collected at 10-weeks
|
|
Visceral fat
Time Frame: Collected at 10-weeks
|
Volume of visceral fat
|
Collected at 10-weeks
|
|
Muscle strength
Time Frame: Collected at 10-weeks
|
Strength of quadriceps muscle at a speed of 60 degrees per second
|
Collected at 10-weeks
|
|
400 meter walk
Time Frame: Collected at 10-weeks
|
Time to walk 400 meters
|
Collected at 10-weeks
|
|
Stair climb time
Time Frame: Collected at 10-weeks
|
Time to ascend and descend 12 stairs
|
Collected at 10-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2014
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
May 1, 2015
Study Registration Dates
First Submitted
July 4, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (ACTUAL)
July 15, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00025941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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