Status:
TERMINATED
Nutritional Supplementation in the Elderly With Weight Loss
Lead Sponsor:
University of California, Los Angeles
Conditions:
Sarcopenia
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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...
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04350762
Start Date
September 5 2019
End Date
December 15 2020
Last Update
May 6 2023
Active Locations (1)
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1
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States, 90095