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Dietary Supplement

Protein + Alkali Supplements for Muscle Health in Older Adults

N/A
Waitlist Available
Led By Lisa Ceglia, MD MS
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Underactive
Habitual dietary intake of protein of ≤0.8 g/kg/d
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights

Study Summary

This trial will study the effects of a high protein diet with and without an alkaline supplement on muscle performance and mass in older adults.

Who is the study for?
This trial is for older adults (65+) who are underactive, have a low protein diet, and can sign an informed consent. They must have adequate kidney function but cannot participate if they have high potassium levels, recent heavy medication use, certain diseases like Crohn's or untreated thyroid issues, excessive alcohol consumption, recent fractures or cancer treatments, dietary restrictions like vegetarianism, or take specific medications.Check my eligibility
What is being tested?
The study tests whether adding potassium bicarbonate to a high-protein diet enhances muscle mass and performance in older adults with typically low protein intake. Participants will receive either whey protein isolate alone or combined with the alkaline salt supplement to see which is more effective.See study design
What are the potential side effects?
Possible side effects may include digestive discomfort due to increased protein intake and potential changes in blood chemistry from the alkali supplement. Specific reactions will vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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This criterion means that the participant has a condition where something in the body is not working as it should.
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You usually eat less than 0.8 grams of protein per kilogram of body weight per day.
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People who can walk around and live in their own homes.
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You are 65 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
24 hour urinary nitrogen excretion to nitrogen intake
appendicular lean body mass
handgrip strength
+3 more
Other outcome measures
D3-creatine dilution (exploratory)

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: whey protein isolate + KHCO3Active Control2 Interventions
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
Group II: whey protein isolate + microcrystalline celluloseActive Control2 Interventions
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
Group III: maltodextrin powder + KHCO3Active Control2 Interventions
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
Group IV: maltodextrin powder + microcrystalline cellulosePlacebo Group2 Interventions
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Find a Location

Who is running the clinical trial?

Tufts UniversityLead Sponsor
263 Previous Clinical Trials
661,633 Total Patients Enrolled
9 Trials studying Sarcopenia
583 Patients Enrolled for Sarcopenia
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,923 Total Patients Enrolled
24 Trials studying Sarcopenia
1,457 Patients Enrolled for Sarcopenia
Lisa Ceglia, MD MS5.04 ReviewsPrincipal Investigator - Tufts Medical Center and Tufts University
Tufts Medical Center
Medical School - New York University
New York University Medical Center, Residency in Internal Medicine
5Patient Review
It was great!

Media Library

Whey Protein Isolate (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04048616 — N/A
Sarcopenia Research Study Groups: whey protein isolate + KHCO3, whey protein isolate + microcrystalline cellulose, maltodextrin powder + KHCO3, maltodextrin powder + microcrystalline cellulose
Sarcopenia Clinical Trial 2023: Whey Protein Isolate Highlights & Side Effects. Trial Name: NCT04048616 — N/A
Whey Protein Isolate (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04048616 — N/A

Frequently Asked Questions

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

What is the uppermost limit of participants in this medical experiment?

"Affirmative. The research hosted on clinicaltrials.gov verifies that this medical trial, which was first announced on November 1st 2019, is actively recruiting participants. A total of 120 individuals must be recruited from a single centre."

Answered by AI

Is enrollment for this experiment currently available to participants?

"Clinicaltrials.gov asserts that this clinical trial is seeking out participants, with the original posting dating back to November 1st 2019 and being updated as recently as April 26th 2022."

Answered by AI
~26 spots leftby Apr 2025