Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04048616
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2019-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Sponsor:
Organization:
Raw JSON
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False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 24 weeks', 'description': 'Standard definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Whey Protein Isolate + KHCO3', 'description': '1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3\n\nwhey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal\n\npotassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 22, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Whey Protein Isolate + Microcrystalline Cellulose', 'description': '1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules\n\nwhey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal\n\nmicrocrystalline cellulose: identical placebo capsule', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 14, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Maltodextrin Powder + KHCO3', 'description': 'isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3\n\npotassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal\n\nmaltodextrin powder: isocaloric placebo powder', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 18, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Maltodextrin Powder + Microcrystalline Cellulose', 'description': 'isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules\n\nmicrocrystalline cellulose: identical placebo capsule\n\nmaltodextrin powder: isocaloric placebo powder', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 14, 'seriousNumAtRisk': 35, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Pedal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'coronary heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign Positional Vertgo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infections', 'stats': 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0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cerebrovascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 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level', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whey Protein Isolate + KHCO3', 'description': '1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3\n\nwhey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal\n\npotassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal'}, {'id': 'FG001', 'title': 'Whey Protein Isolate + Microcrystalline Cellulose', 'description': '1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules\n\nwhey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal\n\nmicrocrystalline cellulose: identical placebo capsule'}, {'id': 'FG002', 'title': 'Maltodextrin Powder + KHCO3', 'description': 'isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3\n\npotassium bicarbonate (KHCO3): 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'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'From July 2021 to July 2023, ambulatory, community-dwelling men and postmenopausal women aged 65 years and older were recruited from direct mailings to the HNRCA volunteer database and the Tufts Medical Center patient database.', 'preAssignmentDetails': 'Exclusion criteria included use of oral glucocorticoids, anabolic and gonadal hormones, alkali-producing antacids, potassium-containing supplements, insulin, uncontrolled diabetes mellitus, kidney stones, advanced chronic kidney disease, cirrhosis, gastroesophageal or intestinal disease, immune disorders, unstable heart disease, untreated thyroid or parathyroid disease, active malignancy or cancer therapy, recent fracture, milk protein allergy, and relevant laboratory abnormalities.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, 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'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.1', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '74.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '74.1', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '72.7', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '74.1', 'spread': '5.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 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'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intention-to-Treat sample of 128 participants with available outcome data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-04', 'size': 633078, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-01T15:24', 'hasProtocol': True}, {'date': '2024-05-23', 'size': 156735, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-01T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'double blind randomized placebo controlled 2x2 factorial design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2019-08-05', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-01', 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'D3-creatine Muscle Mass/Weight', 'timeFrame': '24 weeks', 'description': 'measure of total body percent muscle mass by D3-creatine dilution method'}], 'primaryOutcomes': [{'measure': 'Double Leg Press Peak Power at 70%', 'timeFrame': '24 weeks', 'description': 'Double leg press peak power at 70% of the 1 repetition maximum'}], 'secondaryOutcomes': [{'measure': 'Double Leg Press Peak Power at 70%', 'timeFrame': '12 weeks', 'description': 'Double leg press peak power at 70% of the 1-repetition maximum'}, {'measure': 'Double Leg Press Peak Power at 40%', 'timeFrame': '24 weeks', 'description': 'Double leg press peak power at 40% of the 1 repetition maximum'}, {'measure': 'Double Leg Press Peak Power at 40%', 'timeFrame': '12 weeks', 'description': 'Double leg press peak power at 40% of the 1 repetition maximum'}, {'measure': 'Knee Extension Peak Torque', 'timeFrame': '24 weeks', 'description': 'Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer'}, {'measure': 'Knee Extension Peak Torque', 'timeFrame': '12 weeks', 'description': 'Knee extension peak torque at 60 degrees/s using Biodex Isokinetic Dynamometer'}, {'measure': 'Handgrip Strength', 'timeFrame': '24 weeks', 'description': 'Measure maximum handgrip strength in either hand using handheld Jamar+ dynamometer'}, {'measure': 'Appendicular Lean Body Mass/Height Squared', 'timeFrame': '24 weeks', 'description': 'Dual energy X-ray absorptiometry (DXA) lean mass of arms plus legs divided by height squared'}, {'measure': 'Physical Performance Battery Score', 'timeFrame': '24 weeks', 'description': 'Performance score (range 0-4 with higher values representing a better performance) based on Health Aging and Body Composition-Physical Performance Battery'}, {'measure': '24 Hour Urinary Total Nitrogen Excretion', 'timeFrame': '24 weeks', 'description': 'Measure based on 24 hour urine total nitrogen excretion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Sarcopenia', 'Muscle Loss']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ability to sign informed consent form\n2. ambulatory community-dwelling men and women\n3. age 65 years and over\n4. habitual dietary intake of protein of ≤0.8 g/kg/d\n5. underactive\n6. estimated glomerular filtration rate ≥ 50 ml/min/1.73 m2\n\nExclusion Criteria:\n\n1. participation in a diet or intensive exercise program during the study\n2. vegetarian (no animal protein)\n3. oral glucocorticoid use for \\> 10 days in the last 3 months\n4. anabolic and gonadal hormones in the last 6 months\n5. Tamoxifen/raloxifene in the last 6 months\n6. regular use of alkali-producing antacids (\\> 3 times per week)\n7. potassium-containing supplements or products\n8. non-steroidal anti-inflammatory medications \\>3 times per week\n9. antacids containing calcium carbonate, aluminum hydroxide, magnesium hydroxide, or calcium acetate\n10. insulin\n11. sulfonylureas\n12. SGLT2 inhibitors\n13. a lower extremity fracture in the last year\n14. kidney stones in the past 5 years\n15. hyperkalemia\n16. elevated serum bicarbonate\n17. hypercalcemia\n18. uncontrolled diabetes mellitus defined as having fasting blood \\>150 or hemoglobin A1c \\>8%\n19. untreated thyroid or parathyroid disease\n20. significant immune disorder\n21. current unstable heart disease\n22. Crohn's disease\n23. active malignancy or cancer therapy in the last year\n24. alcohol use exceeding 2 drinks/day\n25. current peptic ulcers or esophageal stricture\n26. other condition or abnormality in screening labs, at discretion of the study physician"}, 'identificationModule': {'nctId': 'NCT04048616', 'briefTitle': 'Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults', 'orgStudyIdInfo': {'id': '3010'}, 'secondaryIdInfos': [{'id': '1R01AG055443-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG055443-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'whey protein isolate + KHCO3', 'description': '1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3', 'interventionNames': ['Dietary Supplement: whey protein isolate', 'Dietary Supplement: potassium bicarbonate (KHCO3)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'whey protein isolate + microcrystalline cellulose', 'description': '1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules', 'interventionNames': ['Dietary Supplement: whey protein isolate', 'Other: microcrystalline cellulose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'maltodextrin powder + KHCO3', 'description': 'isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3', 'interventionNames': ['Dietary Supplement: potassium bicarbonate (KHCO3)', 'Other: maltodextrin powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'maltodextrin powder + microcrystalline cellulose', 'description': 'isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules', 'interventionNames': ['Other: microcrystalline cellulose', 'Other: maltodextrin powder']}], 'interventions': [{'name': 'whey protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one 15-25 gm (based on body weight) protein packet three times a day with each meal', 'armGroupLabels': ['whey protein isolate + KHCO3', 'whey protein isolate + microcrystalline cellulose']}, {'name': 'potassium bicarbonate (KHCO3)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'two 13.5 mmol capsules three times a day with each meal', 'armGroupLabels': ['maltodextrin powder + KHCO3', 'whey protein isolate + KHCO3']}, {'name': 'microcrystalline cellulose', 'type': 'OTHER', 'description': 'identical placebo capsule', 'armGroupLabels': ['maltodextrin powder + microcrystalline cellulose', 'whey protein isolate + microcrystalline cellulose']}, {'name': 'maltodextrin powder', 'type': 'OTHER', 'description': 'isocaloric placebo powder', 'armGroupLabels': ['maltodextrin powder + KHCO3', 'maltodextrin powder + microcrystalline cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lisa Ceglia, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center and Tufts University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Lisa Ceglia', 'investigatorAffiliation': 'Tufts University'}}}}