Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults

NCT04048616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-05-18

Study results available
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Summary

The central hypothesis is that higher protein intake and a neutralizing alkaline salt supplement will improve muscle performance and mass, compared to their respective placebos, in older men and postmenopausal women.

Conditions

  • Age-Related Sarcopenia
  • Muscle Loss

Interventions

DIETARY_SUPPLEMENT

whey protein isolate

one 15-25 gm (based on body weight) protein packet three times a day with each meal

DIETARY_SUPPLEMENT

potassium bicarbonate (KHCO3)

two 13.5 mmol capsules three times a day with each meal

OTHER

microcrystalline cellulose

identical placebo capsule

OTHER

maltodextrin powder

isocaloric placebo powder

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Tufts University

    lead OTHER

Principal Investigators

  • Lisa Ceglia, MD MS · Tufts Medical Center and Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-12-21
Completion
2023-12-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04048616 on ClinicalTrials.gov