SarcopeniaElderlyNCT04350762
Nutritional Supplementation in the Elderly With Weight Loss
A study testing Protein shake + Fish Oil in people with Sarcopenia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Many elderly experience weight loss and weakness with normal aging. Although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein shake + Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female age 65 and older
- Non-smokers
- Weight loss >3% body weight over 6-12 months
- BMI ≤ 25
- Living independently or in an assisted living facility
Who cannot join
- Medical conditions that would lead to weight loss
- Active cancer undergoing treatment (chemotherapy, radiation therapy, or planned surgical intervention)
- CKD stage IV-V (eGFR <30) based on medical records within the last 12 months
- Presence of dysphagia or odynophagia
- Actively taking blood thinner such as Warfarin
- Known history of cirrhosis with presence of ascites
Show all 24Show fewer
- History of a surgical procedure for weight loss (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, lap-band)
- Any abnormal lab findings outside of normal limits as determined by the investigator
- Dietary conditions
- Diet restrictions including vegetarianism, veganism, soy-free diet,
- Fish and/or fish oil allergy or intolerance
- Milk allergy excluding lactose intolerance
- Follows a kosher diet
- Medications
- Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
- Does not include medications used for depression (e.g. mirtazapine, paxil) if patient has been on a stable dose of this medication for at least 3 months prior to the start of this study
- If participant is already taking a fish oil supplement, he/she must be willing to either stop the supplement or take the supplement the investigators are using in the study depending on the randomization assignment
- Additional
- Patient has implantable device such as a pacemaker or ICD
- Unable to complete 6-minute walk test at baseline
- Hospitalization within the last 30 days
- Participation in a therapeutic research study within 30 days of baseline
- Living in a skilled nursing facility or long-term care facility
- Any other medical condition that principal investigator or co-investigators deem would preclude the patient from study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, 90095
About this study
Many elderly experience weight loss and weakness with normal aging. Although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. The aim of this study is to examine the effect of dietary prescription with or without nutrition supplementation that includes soy protein, whey protein and fish oil in elderly patients who have suffered unintentional weight loss.
Read the detailed description
This is an 8-week, randomized, pilot study with elderly subjects (age 65 and older) with recent unintentional weight loss who will receive either two servings of supplement powder and fish oil or no dietary supplementation (N=10 for each group).
- Conditions
- Sarcopenia
- Being tested
- Protein shake + Fish Oil
- Keywords
- Elderly, protein supplementation, unintentional weight loss
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein shake + Fish OilDietary supplement
2 shakes of protein as well as 1 fish oil daily.
| Study group | Role | What they receive |
|---|---|---|
| Supplement + Fish Oil | Experimental | Participants will mix 5 scoops of powdered nutrition supplement with 8 oz of cold water (2x/day). The supplemental shake will be consumed on two separate occasions daily. Omega-3 fish oil supplement is in capsule form for intake once daily.
The NutraWell nutrition powder and OmegaRich fish oil supplement will be provided by and distributed from DoWell Laboratories (Irvine, CA - USA). Receives: Dietary Supplement: Protein shake + Fish Oil |
| Control | No intervention | No dietary supplements. Participants will continue current intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.
Measured: 8 weeks
Nutritional Status
To assess if increased protein supplementation and fish oil has impact on nutrition status using Mini Nutritional Assessment questionnaire (minimum value 0, maximum value 14), where higher scores correlate to better nutritional status and lower scores indicate malnutrition.
Measured: 8 weeks
Functional Improvements
To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start5 Sep 2019
- Primary completion15 Sep 2020
- Study completion15 Dec 2020
Why it stopped: Unable to enroll due to Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350762
- Sponsor's protocol ID
- 18-001995
- Acronym
- Elderly
- Status last verified
- May 2023
- First submitted
- 10 Apr 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation in the Elderly With Weight Loss
- ClinicalTrials.gov ID
- NCT04350762
- Acronym / sponsor ID
- Elderly / 18-001995
- Conditions
- Sarcopenia
- Keywords
- Elderly, protein supplementation, unintentional weight loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll due to Pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many elderly experience weight loss and weakness with normal aging. Although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. The aim of this study is to examine the effect of dietary prescription with or without nutrition supplementation that includes soy protein, whey protein and fish oil in elderly patients who have suffered unintentional weight loss.
Detailed description
This is an 8-week, randomized, pilot study with elderly subjects (age 65 and older) with recent unintentional weight loss who will receive either two servings of supplement powder and fish oil or no dietary supplementation (N=10 for each group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement + Fish Oil | Experimental | Dietary Supplement: Protein shake + Fish OilParticipants will mix 5 scoops of powdered nutrition supplement with 8 oz of cold water (2x/day). The supplemental shake will be consumed on two separate occasions daily. Omega-3 fish oil supplement is in capsule form for intake once daily. The NutraWell nutrition powder and OmegaRich fish oil supplement will be provided by and distributed from DoWell Laboratories (Irvine, CA - USA). |
| Control | No intervention | –No dietary supplements. Participants will continue current intake. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male or female age 65 and older
- Non-smokers
- Weight loss >3% body weight over 6-12 months
- BMI ≤ 25
- Living independently or in an assisted living facility
Key exclusion criteria (24 listed)
- Medical conditions that would lead to weight loss
- Dietary conditions
- Medications
- Additional
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 |
|---|---|---|
| Protein shake + Fish Oil2 shakes of protein as well as 1 fish oil daily. | Dietary supplement | Supplement + Fish Oil |
Primary outcome
Body Composition
Time frame: 8 weeks
To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.
Nutritional Status
Time frame: 8 weeks
To assess if increased protein supplementation and fish oil has impact on nutrition status using Mini Nutritional Assessment questionnaire (minimum value 0, maximum value 14), where higher scores correlate to better nutritional status and lower scores indicate malnutrition.
Functional Improvements
Time frame: 8 weeks
To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.
Results and safety
The study was stopped early (reason given: Unable to enroll due to Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
Zhaoping Li principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein shake + Fish Oil in people with Sarcopenia, run by University of California, Los Angeles 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 5 inclusion and 24 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: stopped early, as of the sponsor's last update on 6 May 2023. 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. 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?
The study was stopped early (reason given: Unable to enroll due to Pandemic). Results are not available in the source record.
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?
Body Composition (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.