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Beetroot Juice Resistance Training Older Adults

Primary Purpose

Sarcopenia, Old Age; Atrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BRJ+Nitrate
Control
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BRJ+Nitrate

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Whole body fat free mass
    Mass of fat free tissue
    Whole body fat mass
    Mass of fat tissue
    Thigh muscle
    Volume of thigh muscle
    Thigh intermuscular fat
    Volume of fat in the thigh muscle
    Thigh subcutaneous fat
    Volume of subcutaneous fat in the thigh
    Visceral fat
    Volume of visceral fat
    Muscle strength
    Strength of quadriceps muscle at a speed of 60 degrees per second
    400 meter walk
    Time to walk 400 meters
    Stair climb time
    Time to ascend and descend 12 stairs
    Peak oxygen consumption
    Peak oxygen consumed at maximal exercise during graded exercise testing
    Whole body fat free mass
    mass of fat free tissue
    Whole body fat mass
    Mass of fat tissue
    Thigh muscle
    Volume of thigh muscle
    Thigh intermuscular fat
    Volume of fat in the thigh muscle
    Thigh subcutaneous fat
    Volume of subcutaneous fat in the thigh
    Visceral fat
    Volume of visceral fat
    Muscle strength
    Strength of quadriceps muscle at a speed of 60 degrees per second
    400 meter walk
    Time to walk 400 meters
    Stair climb time
    Time to ascend and descend 12 stairs

    Secondary Outcome Measures

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    July 12, 2022
    Sponsor
    Wake Forest University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05460351
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (Actual)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wake Forest University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia, Old Age; Atrophy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    A third party not involved with the conduct of the study provided research staff with the beetroot juice in participant specific coded bottles. The research staff then distributed these coded bottles to the participant. At the end of the trial, the code was revealed for intervention assignment.
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BRJ+Nitrate
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    BRJ+Nitrate
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Control
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Whole body fat free mass
    Description
    Mass of fat free tissue
    Time Frame
    Collected at baseline
    Title
    Whole body fat mass
    Description
    Mass of fat tissue
    Time Frame
    Collected at baseline
    Title
    Thigh muscle
    Description
    Volume of thigh muscle
    Time Frame
    Collected at baseline
    Title
    Thigh intermuscular fat
    Description
    Volume of fat in the thigh muscle
    Time Frame
    Collected at baseline
    Title
    Thigh subcutaneous fat
    Description
    Volume of subcutaneous fat in the thigh
    Time Frame
    Collected at baseline
    Title
    Visceral fat
    Description
    Volume of visceral fat
    Time Frame
    Collected at baseline
    Title
    Muscle strength
    Description
    Strength of quadriceps muscle at a speed of 60 degrees per second
    Time Frame
    Collected at baseline
    Title
    400 meter walk
    Description
    Time to walk 400 meters
    Time Frame
    Collected at baseline
    Title
    Stair climb time
    Description
    Time to ascend and descend 12 stairs
    Time Frame
    Collected at baseline
    Title
    Peak oxygen consumption
    Description
    Peak oxygen consumed at maximal exercise during graded exercise testing
    Time Frame
    Collected at baseline
    Title
    Whole body fat free mass
    Description
    mass of fat free tissue
    Time Frame
    Collected at 10-weeks
    Title
    Whole body fat mass
    Description
    Mass of fat tissue
    Time Frame
    Collected at 10-weeks
    Title
    Thigh muscle
    Description
    Volume of thigh muscle
    Time Frame
    Collected at 10-weeks
    Title
    Thigh intermuscular fat
    Description
    Volume of fat in the thigh muscle
    Time Frame
    Collected at 10-weeks
    Title
    Thigh subcutaneous fat
    Description
    Volume of subcutaneous fat in the thigh
    Time Frame
    Collected at 10-weeks
    Title
    Visceral fat
    Description
    Volume of visceral fat
    Time Frame
    Collected at 10-weeks
    Title
    Muscle strength
    Description
    Strength of quadriceps muscle at a speed of 60 degrees per second
    Time Frame
    Collected at 10-weeks
    Title
    400 meter walk
    Description
    Time to walk 400 meters
    Time Frame
    Collected at 10-weeks
    Title
    Stair climb time
    Description
    Time to ascend and descend 12 stairs
    Time Frame
    Collected at 10-weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Beetroot Juice Resistance Training Older Adults

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