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

NCT04048616 | Completed Results DMC

• 2 other identifiers: 30101R01AG055443-01A1
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Double Leg Press Peak Power at 70%

  Double leg press peak power at 70% of the 1 repetition maximum

  24 weeks

Secondary Outcomes (9)

• Double Leg Press Peak Power at 70%

  12 weeks

• Double Leg Press Peak Power at 40%

  24 weeks

• Double Leg Press Peak Power at 40%

  12 weeks

• Knee Extension Peak Torque

  24 weeks

• Knee Extension Peak Torque

  12 weeks

Other Outcomes (1)

• D3-creatine Muscle Mass/Weight

  24 weeks

Study Arms (4)

whey protein isolate + KHCO3

ACTIVE COMPARATOR

1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3

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

Dietary Supplement: whey protein isolate; Other: microcrystalline cellulose

maltodextrin powder + KHCO3

ACTIVE COMPARATOR

isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3

Dietary Supplement: potassium bicarbonate (KHCO3); Other: maltodextrin powder

maltodextrin powder + microcrystalline cellulose

PLACEBO COMPARATOR

isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules

Other: microcrystalline cellulose; Other: maltodextrin powder

Interventions

whey protein isolate DIETARY_SUPPLEMENT

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

whey protein isolate + KHCO3; whey protein isolate + microcrystalline cellulose

potassium bicarbonate (KHCO3) DIETARY_SUPPLEMENT

two 13.5 mmol capsules three times a day with each meal

maltodextrin powder + KHCO3; whey protein isolate + KHCO3

microcrystalline cellulose OTHER

identical placebo capsule

maltodextrin powder + microcrystalline cellulose; whey protein isolate + microcrystalline cellulose

maltodextrin powder OTHER

isocaloric placebo powder

maltodextrin powder + KHCO3; maltodextrin powder + microcrystalline cellulose

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Tufts University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

potassium bicarbonate; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Lisa Ceglia, MD MS
• Organization: Tufts University and Tufts Medical Center

lisa.ceglia@tuftsmedicine.org

(617) 636-8171

Study Officials

• Lisa Ceglia, MD MS

  Tufts Medical Center and Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: double blind randomized placebo controlled 2x2 factorial design

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: July 1, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)