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Dietary Supplement
Protein + Alkali Supplements for Muscle Health in Older Adults
N/A
Waitlist Available
Led By Lisa Ceglia, MD MS
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
Study Summary
This trial will study the effects of a high protein diet with and without an alkaline supplement on muscle performance and mass in older adults.
Who is the study for?
This trial is for older adults (65+) who are underactive, have a low protein diet, and can sign an informed consent. They must have adequate kidney function but cannot participate if they have high potassium levels, recent heavy medication use, certain diseases like Crohn's or untreated thyroid issues, excessive alcohol consumption, recent fractures or cancer treatments, dietary restrictions like vegetarianism, or take specific medications.Check my eligibility
What is being tested?
The study tests whether adding potassium bicarbonate to a high-protein diet enhances muscle mass and performance in older adults with typically low protein intake. Participants will receive either whey protein isolate alone or combined with the alkaline salt supplement to see which is more effective.See study design
What are the potential side effects?
Possible side effects may include digestive discomfort due to increased protein intake and potential changes in blood chemistry from the alkali supplement. Specific reactions will vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
24 hour urinary nitrogen excretion to nitrogen intake
appendicular lean body mass
handgrip strength
+3 moreOther outcome measures
D3-creatine dilution (exploratory)
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: whey protein isolate + KHCO3Active Control2 Interventions
1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3
Group II: whey protein isolate + microcrystalline celluloseActive Control2 Interventions
1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules
Group III: maltodextrin powder + KHCO3Active Control2 Interventions
isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3
Group IV: maltodextrin powder + microcrystalline cellulosePlacebo Group2 Interventions
isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules
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Who is running the clinical trial?
Tufts UniversityLead Sponsor
263 Previous Clinical Trials
661,633 Total Patients Enrolled
9 Trials studying Sarcopenia
583 Patients Enrolled for Sarcopenia
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,923 Total Patients Enrolled
24 Trials studying Sarcopenia
1,457 Patients Enrolled for Sarcopenia
Lisa Ceglia, MD MS5.04 ReviewsPrincipal Investigator - Tufts Medical Center and Tufts University
Tufts Medical Center
Medical School - New York University
New York University Medical Center, Residency in Internal Medicine
5Patient Review
It was great!
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that the participant has a condition where something in the body is not working as it should.Your kidney function is good, with an estimated filtration rate of at least 50 ml/min/1.73 m2.You usually eat less than 0.8 grams of protein per kilogram of body weight per day.You have high levels of potassium in your blood.You have taken oral steroids for more than 10 days in the last 3 months.You have taken tamoxifen or raloxifene in the past 6 months.You have not received treatment for thyroid or parathyroid disease.You have a serious immune system disorder.You have Crohn's disease.You drink more than 2 alcoholic drinks every day.You have peptic ulcers or a narrow esophagus.The study doctor will decide if any other health issues might make it unsafe for you to participate.You have had kidney stones in the last 5 years.Your blood has too much bicarbonate in it.You do not eat any animal protein.It seems like the criterion you provided is just the word "insulin." It's not clear what you're asking for. Can you please provide more context or clarify your request?Taking sulfonylurea medications.You have broken a bone in your leg in the past year.You have had cancer or cancer treatment in the past year.You have taken certain hormones in the last 6 months.You are not allowed to join a special diet or exercise program during the study.High levels of calcium in the blood.Your diabetes is not well controlled, with high fasting blood sugar or hemoglobin A1c levels.You take antacids that produce alkali more than three times a week on a regular basis.You are taking potassium supplements or products.You take non-steroidal anti-inflammatory drugs more than 3 times a week.You are taking antacids with certain ingredients like calcium carbonate or aluminum hydroxide.This criterion refers to the exclusion of individuals who are using SGLT2 inhibitors, which are a type of medication used to treat diabetes. If you are taking SGLT2 inhibitors, you may be excluded from the clinical trial.People who can walk around and live in their own homes.You are 65 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: whey protein isolate + KHCO3
- Group 2: whey protein isolate + microcrystalline cellulose
- Group 3: maltodextrin powder + KHCO3
- Group 4: maltodextrin powder + microcrystalline cellulose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost limit of participants in this medical experiment?
"Affirmative. The research hosted on clinicaltrials.gov verifies that this medical trial, which was first announced on November 1st 2019, is actively recruiting participants. A total of 120 individuals must be recruited from a single centre."
Answered by AI
Is enrollment for this experiment currently available to participants?
"Clinicaltrials.gov asserts that this clinical trial is seeking out participants, with the original posting dating back to November 1st 2019 and being updated as recently as April 26th 2022."
Answered by AI
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