Nutritional Supplementation in the Elderly With Weight Loss
NCT ID: NCT04350762
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2019-09-05
2020-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Supplement + Fish Oil
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).
Protein shake + Fish Oil
2 shakes of protein as well as 1 fish oil daily.
Control
No dietary supplements. Participants will continue current intake.
No interventions assigned to this group
Interventions
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Protein shake + Fish Oil
2 shakes of protein as well as 1 fish oil daily.
Eligibility Criteria
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Inclusion Criteria
* Non-smokers
* Weight loss \>3% body weight over 6-12 months
* BMI ≤ 25
* Living independently or in an assisted living facility
Exclusion Criteria
* 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
* 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
65 Years
ALL
Yes
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Zhaoping Li
Chief / Professor of Medicine
Principal Investigators
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Zhaoping Li
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States
Countries
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Other Identifiers
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18-001995
Identifier Type: -
Identifier Source: org_study_id
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