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Antioxidants for Vascular and Muscle Health During Inactivity

N/A
Recruiting
Research Sponsored by Joel Trinity
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 65-85 years
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights

Study Summary

This trial is investigating how reduced activity affects muscle and vascular function, and how these changes are related. The goal is to understand how to reduce the negative impact of these changes.

Who is the study for?
This trial is for older adults aged 65-85 with good cognitive health (MOCA score ≥26) and normal kidney function. They must not be on a weight-loss diet, have a BMI over 35, or smoke. Those with recent cancer treatment, heavy smoking history, drug/alcohol abuse, or who exercise regularly are excluded.Check my eligibility
What is being tested?
The study tests the effects of bed rest combined with antioxidants (MITO-AO and PB-125) versus placebo on vascular and muscle function in aging individuals. It includes passive leg movements and strength tests to understand how oxidative stress contributes to dysfunction during inactivity.See study design
What are the potential side effects?
Potential side effects may include reactions related to antioxidant supplements such as gastrointestinal discomfort or allergic responses. Bed rest can lead to muscle weakness, decreased bone density, and possible cardiovascular changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 65 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood vessel diameter after PLM
Change in blood vessel flow rate after PLM
Secondary outcome measures
Change in O2 augmented maximal mitochondrial oxidative capacity (Vmax) after plantar flexion
Change in adenosine triphosphate (ATP) concentration after plantar flexion
Change in inorganic phosphate concentration [Pi] after plantar flexion
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PB-125Experimental Treatment5 Interventions
Healthy older adult subjects ages 65-75 will take the supplement PB-125 during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply.
Group II: MITO-AOExperimental Treatment5 Interventions
Healthy older adult subjects ages 65-75 will take the supplement MITO-AO during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (31P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply.
Group III: PlaceboPlacebo Group5 Interventions
Healthy older adult subjects ages 65-75 will take placebo during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,365 Total Patients Enrolled
6 Trials studying Aging
3,338 Patients Enrolled for Aging
Joel TrinityLead Sponsor

Media Library

Isometric knee extensor test Clinical Trial Eligibility Overview. Trial Name: NCT04351113 — N/A
Aging Research Study Groups: Placebo, PB-125, MITO-AO
Aging Clinical Trial 2023: Isometric knee extensor test Highlights & Side Effects. Trial Name: NCT04351113 — N/A
Isometric knee extensor test 2023 Treatment Timeline for Medical Study. Trial Name: NCT04351113 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the prerequisites to join this clinical investigation?

"Eligible patients are those who possess antioxidants and have an age between 65 to 85 years old. Approximately 72 participants need to be enrolled in the trial."

Answered by AI

Are there current opportunities for enrollment in this trial?

"Right, as evidenced by clinicaltrials.gov data, this medical research is actively looking for participants to join the study. It was initially posted on September 1st 2019 and most recently updated on April 14th 2022. They need 72 volunteers from a single site to take part in the trial."

Answered by AI

What is the scope of involvement for this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this trial, which was initially posted on the 1st of September 2019, is currently recruiting participants. 72 patients are needed from a single location for participation in the study."

Answered by AI

Can individuals below the age of 55 participate in this experiment?

"This clinical trial seeks to enroll patients aged 65 to 85, with a total of 260 participants in the program. Of these, 2 are under 18 and 258 will be over that age threshold."

Answered by AI
~20 spots leftby Dec 2025