NCT05460351

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 4, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (19)

  • Whole body fat free mass

    Mass of fat free tissue

    Collected at baseline

  • Whole body fat mass

    Mass of fat tissue

    Collected at baseline

  • Thigh muscle

    Volume of thigh muscle

    Collected at baseline

  • Thigh intermuscular fat

    Volume of fat in the thigh muscle

    Collected at baseline

  • Thigh subcutaneous fat

    Volume of subcutaneous fat in the thigh

    Collected at baseline

  • Visceral fat

    Volume of visceral fat

    Collected at baseline

  • Muscle strength

    Strength of quadriceps muscle at a speed of 60 degrees per second

    Collected at baseline

  • 400 meter walk

    Time to walk 400 meters

    Collected at baseline

  • Stair climb time

    Time to ascend and descend 12 stairs

    Collected at baseline

  • Peak oxygen consumption

    Peak oxygen consumed at maximal exercise during graded exercise testing

    Collected at baseline

  • Whole body fat free mass

    mass of fat free tissue

    Collected at 10-weeks

  • Whole body fat mass

    Mass of fat tissue

    Collected at 10-weeks

  • Thigh muscle

    Volume of thigh muscle

    Collected at 10-weeks

  • Thigh intermuscular fat

    Volume of fat in the thigh muscle

    Collected at 10-weeks

  • Thigh subcutaneous fat

    Volume of subcutaneous fat in the thigh

    Collected at 10-weeks

  • Visceral fat

    Volume of visceral fat

    Collected at 10-weeks

  • Muscle strength

    Strength of quadriceps muscle at a speed of 60 degrees per second

    Collected at 10-weeks

  • 400 meter walk

    Time to walk 400 meters

    Collected at 10-weeks

  • Stair climb time

    Time to ascend and descend 12 stairs

    Collected at 10-weeks

Study Arms (2)

BRJ+Nitrate

EXPERIMENTAL

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.

Dietary Supplement: BRJ+Nitrate

Control

PLACEBO COMPARATOR

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.

Dietary Supplement: Control

Interventions

BRJ+NitrateDIETARY_SUPPLEMENT

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

BRJ+Nitrate
ControlDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SarcopeniaAtrophy

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 15, 2022

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share