BridgeMD
Compares treatment options for Protein Metabolism
Official title Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
ClinicalTrials.gov ID: NCT07254403
What this study is testing
- What it's testing
- Frailty is a common clinical syndrome in older adults that increases the risk for poor health outcomes including falls, disability, hospitalization, and mortality. Previous research showed increased protein needs and reduced anabolic response to meals in older adults, indicating the need for proteins with a high anabolic capacity to prevent and attenuate physical and cognitive health decline throughout the frailty cycle.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 95. Healthy volunteers may be eligible.
You may be able to join if
- Age 65-95 years old
- Ability to walk, sit down, and stand up (independently or with walking assistance device)
- No recent use (\< 4 weeks prior to start of the study) of dietary supplements and medication influencing protein and amino acid metabolism (e.g...
- Willingness to lay supine in bed for up to 6 hours
- Willingness and ability to comply with the protocol
You likely can't join if
- Presence of malnutrition (BMI \ 35 kg/m2 to avoid weight-related metabolic disturbances,
- Established diagnosis and active treatment of chronic disease: Insulin-dependent diabetes mellitus, active malignancy, heart disease, kidney disease...
- History of untreated metabolic disease including hepatic or renal disorder
- Presence of fever within the last 3 days
- Cirrhosis of liver
- Diagnosis of dementia, neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia).
See the full eligibility criteria
- Age 65-95 years old
- Ability to walk, sit down, and stand up (independently or with walking assistance device)
- No recent use (\< 4 weeks prior to start of the study) of dietary supplements and medication influencing protein and amino acid metabolism (e.g., antibiotics, oral corticosteroids)
- Willingness to lay supine in bed for up to 6 hours
- Willingness and ability to comply with the protocol
- Presence of malnutrition (BMI \ 35 kg/m2 to avoid weight-related metabolic disturbances,
- Established diagnosis and active treatment of chronic disease: Insulin-dependent diabetes mellitus, active malignancy, heart disease, kidney disease, liver disease, HIV/AIDS, Asthma (moderate to severe), Hep (A, B, or C)
- History of untreated metabolic disease including hepatic or renal disorder
- Presence of fever within the last 3 days
- Cirrhosis of liver
- Diagnosis of dementia, neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia).
- (Possible) pregnancy
- Presence of acute illness or metabolically unstable chronic illness
- Active dependence on alcohol or drugs
- Newly prescribed long-term oral corticosteroids
- Planned elective surgery requiring 2 or more days of hospitalization during the entire study
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject
- Already enrolled in another clinical trial
- Any condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- Known allergy to any of the components of the feeding (soy, beef)
- Established daily diet of vegetarian/vegan composition
The study team makes the final eligibility decision.
Where it's taking place
- College Station, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 95 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include College Station, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.