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Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
NCT04048616 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT whey protein isolate
- DIETARY_SUPPLEMENT potassium bicarbonate (KHCO3)
- OTHER microcrystalline cellulose
- OTHER maltodextrin powder
Study Locations (1)
Massachusetts
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2023-12-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04048616
The ClinicalTrials.gov registry entry for NCT04048616 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Muscle Loss appearing as the primary indexed condition, and to 4 interventions — of which whey protein isolate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04048616 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04048616 about?
NCT04048616 is a clinical study titled "Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults". 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.
What is the current status of trial NCT04048616?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2021-07-01. Estimated completion is 2023-12-21.
What conditions does trial NCT04048616 study?
This clinical trial studies the following conditions: Muscle Loss, Age-Related Sarcopenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04048616?
The interventions under investigation include: whey protein isolate (DIETARY_SUPPLEMENT), potassium bicarbonate (KHCO3) (DIETARY_SUPPLEMENT), microcrystalline cellulose (OTHER), maltodextrin powder (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04048616?
This trial is sponsored by Tufts University, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04048616 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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