Age-Related SarcopeniaNCT04048616
Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
A study testing whey protein isolate, potassium bicarbonate (KHCO3) and microcrystalline cellulose in people with Age-Related Sarcopenia and Muscle Loss, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Sarcopenia, Muscle Loss
- What is being tested?
- whey protein isolate, potassium bicarbonate (KHCO3) and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ability to sign informed consent form
- ambulatory community-dwelling men and women
- age 65 years and over
- habitual dietary intake of protein of ≤0.8 g/kg/d
- underactive
- estimated glomerular filtration rate ≥ 50 ml/min/1.73 m2
Who cannot join
- participation in a diet or intensive exercise program during the study
- vegetarian (no animal protein)
- oral glucocorticoid use for > 10 days in the last 3 months
- anabolic and gonadal hormones in the last 6 months
- Tamoxifen/raloxifene in the last 6 months
- regular use of alkali-producing antacids (> 3 times per week)
Show all 26Show fewer
- potassium-containing supplements or products
- non-steroidal anti-inflammatory medications >3 times per week
- antacids containing calcium carbonate, aluminum hydroxide, magnesium hydroxide, or calcium acetate
- insulin
- sulfonylureas
- SGLT2 inhibitors
- a lower extremity fracture in the last year
- kidney stones in the past 5 years
- hyperkalemia
- elevated serum bicarbonate
- hypercalcemia
- uncontrolled diabetes mellitus defined as having fasting blood >150 or hemoglobin A1c >8%
- untreated thyroid or parathyroid disease
- significant immune disorder
- current unstable heart disease
- Crohn's disease
- active malignancy or cancer therapy in the last year
- alcohol use exceeding 2 drinks/day
- current peptic ulcers or esophageal stricture
- other condition or abnormality in screening labs, at discretion of the study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
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.
Read the detailed description
With aging, skeletal muscle mass and performance decline leading to an increased risk of falls and physical disability. There is ongoing research on whether increasing dietary protein intake in older adults improves indices of muscle health and thus translates to a reduction in physical disability. A main concern is that high protein results in a large dietary acid load from the breakdown of protein to acidogenic byproducts, which could in turn promote muscle degradation particularly in older adults with age-related declines in renal excretion of acid. The scientific premise of this project is that the balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on muscle. Preliminary data have suggested that a daily alkaline salt supplement (potassium bicarbonate, KHCO3) lowered the dietary acid load and improved lower extremity muscle power in postmenopausal women.
The investigator's central hypothesis is that higher protein intake and a neutralizing alkaline salt will improve muscle performance and mass, compared to their respective placebos, in older men and postmenopausal women. To test the hypothesis, the investigators conducted a randomized, double-blind, placebo-controlled, 2x2 factorial study in underactive men and women age 65 and older on baseline lower protein diets. Participants were assigned to one of four groups: either a whey protein supplement (to raise protein intake to 1.5 g/kg/d) with or without KHCO3 81 mmol/d or an isocaloric placebo supplement with or without KHCO3 81 mmol/d for 24 wks.
- Conditions
- Age-Related Sarcopenia, Muscle Loss
- Being tested
- whey protein isolate, potassium bicarbonate (KHCO3), microcrystalline cellulose, maltodextrin powder
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein isolateDietary supplement
one 15-25 gm (based on body weight) protein packet three times a day with each meal
potassium bicarbonate (KHCO3)Dietary supplement
two 13.5 mmol capsules three times a day with each meal
microcrystalline celluloseOther
identical placebo capsule
maltodextrin powderOther
isocaloric placebo powder
| Study group | Role | What they receive |
|---|---|---|
| whey protein isolate + KHCO3 | Active comparator | 1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3 Receives: Dietary Supplement: whey protein isolate; Dietary Supplement: potassium bicarbonate (KHCO3) |
| whey protein isolate + microcrystalline cellulose | Active comparator | 1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules Receives: Dietary Supplement: whey protein isolate; Other: microcrystalline cellulose |
| maltodextrin powder + KHCO3 | Active comparator | isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3 Receives: Dietary Supplement: potassium bicarbonate (KHCO3); Other: maltodextrin powder |
| maltodextrin powder + microcrystalline cellulose | Placebo comparator | isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules Receives: Other: microcrystalline cellulose; Other: maltodextrin powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Leg Press Peak Power at 70%
Double leg press peak power at 70% of the 1 repetition maximum
Measured: 24 weeks
Secondary outcomes (9)
Double Leg Press Peak Power at 70%
Double leg press peak power at 70% of the 1-repetition maximum
Measured: 12 weeks
Double Leg Press Peak Power at 40%
Double leg press peak power at 40% of the 1 repetition maximum
Measured: 24 weeks
Double Leg Press Peak Power at 40%
Double leg press peak power at 40% of the 1 repetition maximum
Measured: 12 weeks
Knee Extension Peak Torque
Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Measured: 24 weeks
Knee Extension Peak Torque
Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer
Measured: 12 weeks
Handgrip Strength
Measure maximum handgrip strength in either hand using handheld Jamar+ dynamometer
Measured: 24 weeks
Appendicular Lean Body Mass/Height Squared
Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared
Measured: 24 weeks
Physical Performance Battery Score
Performance score (range 0-4 with higher values representing a better performance) based on Health Aging and Body Composition-Physical Performance Battery
Measured: 24 weeks
24 Hour Urinary Total Nitrogen Excretion
Measure based on 24 hour urine total nitrogen excretion
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Jul 2021
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- double blind randomized placebo controlled 2x2 factorial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lisa Ceglia, Tufts University
- Investigators
- Lisa Ceglia, MD MS, Principal investigator, Tufts Medical Center and Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048616
- Sponsor's protocol ID
- 3010
- Other IDs
- 1R01AG055443-01A1
- Status last verified
- May 2025
- First submitted
- 5 Aug 2019
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceglia L, Konieczynski E, Danico E, Trinquart L, Koethe B, Xiang Q, Fielding RA, Evans WJ, Shankaran M, Dawson-Hughes B. Independent effects of whey protein and alkali supplementation on muscle health in healthy older adults: factorial randomized controlled trial. Am J Clin Nutr. 2026 May;123(5):101257. doi: 10.1016/j.ajcnut.2026.101257. Epub 2026 Mar 2.
PubMed 41780731
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
- ClinicalTrials.gov ID
- NCT04048616
- Acronym / sponsor ID
- 3010
- Conditions
- Age-Related Sarcopenia, Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With aging, skeletal muscle mass and performance decline leading to an increased risk of falls and physical disability. There is ongoing research on whether increasing dietary protein intake in older adults improves indices of muscle health and thus translates to a reduction in physical disability. A main concern is that high protein results in a large dietary acid load from the breakdown of protein to acidogenic byproducts, which could in turn promote muscle degradation particularly in older adults with age-related declines in renal excretion of acid. The scientific premise of this project is that the balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on muscle. Preliminary data have suggested that a daily alkaline salt supplement (potassium bicarbonate, KHCO3) lowered the dietary acid load and improved lower extremity muscle power in postmenopausal women.
The investigator's central hypothesis is that higher protein intake and a neutralizing alkaline salt will improve muscle performance and mass, compared to their respective placebos, in older men and postmenopausal women. To test the hypothesis, the investigators conducted a randomized, double-blind, placebo-controlled, 2x2 factorial study in underactive men and women age 65 and older on baseline lower protein diets. Participants were assigned to one of four groups: either a whey protein supplement (to raise protein intake to 1.5 g/kg/d) with or without KHCO3 81 mmol/d or an isocaloric placebo supplement with or without KHCO3 81 mmol/d for 24 wks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- double blind randomized placebo controlled 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| whey protein isolate + KHCO3 | Active comparator | Dietary Supplement: whey protein isolate, Dietary Supplement: potassium bicarbonate (KHCO3)1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3 |
| whey protein isolate + microcrystalline cellulose | Active comparator | Dietary Supplement: whey protein isolate, Other: microcrystalline cellulose1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules |
| maltodextrin powder + KHCO3 | Active comparator | Dietary Supplement: potassium bicarbonate (KHCO3), Other: maltodextrin powderisocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3 |
| maltodextrin powder + microcrystalline cellulose | Placebo comparator | Other: microcrystalline cellulose, Other: maltodextrin powderisocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- ability to sign informed consent form
- ambulatory community-dwelling men and women
- age 65 years and over
- habitual dietary intake of protein of ≤0.8 g/kg/d
- underactive
Key exclusion criteria (26 listed)
- participation in a diet or intensive exercise program during the study
- vegetarian (no animal protein)
- oral glucocorticoid use for > 10 days in the last 3 months
- anabolic and gonadal hormones in the last 6 months
- Tamoxifen/raloxifene in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protein isolateone 15-25 gm (based on body weight) protein packet three times a day with each meal | Dietary supplement | whey protein isolate + KHCO3, whey protein isolate + microcrystalline cellulose |
| potassium bicarbonate (KHCO3)two 13.5 mmol capsules three times a day with each meal | Dietary supplement | maltodextrin powder + KHCO3, whey protein isolate + KHCO3 |
| microcrystalline celluloseidentical placebo capsule | Other | maltodextrin powder + microcrystalline cellulose, whey protein isolate + microcrystalline cellulose |
| maltodextrin powderisocaloric placebo powder | Other | maltodextrin powder + KHCO3, maltodextrin powder + microcrystalline cellulose |
Primary outcome
Double Leg Press Peak Power at 70%
Time frame: 24 weeks
Double leg press peak power at 70% of the 1 repetition maximum
9 secondary outcomes
Double Leg Press Peak Power at 70%
Time frame: 12 weeks
Double Leg Press Peak Power at 40%
Time frame: 24 weeks
Double Leg Press Peak Power at 40%
Time frame: 12 weeks
Knee Extension Peak Torque
Time frame: 24 weeks
Knee Extension Peak Torque
Time frame: 12 weeks
Handgrip Strength
Time frame: 24 weeks
Appendicular Lean Body Mass/Height Squared
Time frame: 24 weeks
Physical Performance Battery Score
Time frame: 24 weeks
24 Hour Urinary Total Nitrogen Excretion
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41780731Ceglia L, Konieczynski E, Danico E, Trinquart L, Koethe B, Xiang Q, Fielding RA, Evans WJ, Shankaran M, Dawson-Hughes B. Independent effects of whey protein and alkali supplementation on muscle health in healthy older adults: factorial randomized controlled trial. Am J Clin Nutr. 2026 May;123(5):101257. doi: 10.1016/j.ajcnut.2026.101257. Epub 2026 Mar 2.
- Individual participant dataSharing planned: No
Related trials for Age-Related Sarcopenia
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Not yet recruiting
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Active, not recruitingObservational study
Evaluation of the Relationship Between Fall Risk, Muscle Strength, and Anticholinergic Burden in Geriatric Patients Presenting to the Emergency Department
Falls (Accidents) in Old Age, Falls
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Ceglia, MD MS principal investigator
Tufts Medical Center and Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein isolate, potassium bicarbonate (KHCO3) and microcrystalline cellulose in people with Age-Related Sarcopenia and Muscle Loss, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double Leg Press Peak Power at 70% (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.