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TerminatedNCT04350762ElderlyUpdated May 6, 2023

Nutritional Supplementation in the Elderly With Weight Loss

An interventional study of Protein shake + Fish Oil in Sarcopenia, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Other

Why this study was terminated
Unable to enroll due to Pandemic

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Sarcopenia

Keywords

  • Elderly
  • protein supplementation
  • unintentional weight loss
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 4 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    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).

    Dietary Supplement: Protein shake + Fish Oil

  • No intervention
    Control

    No dietary supplements. Participants will continue current intake.

Interventions

  • Dietary supplementProtein shake + Fish Oil

    2 shakes of protein as well as 1 fish oil daily.

06

What researchers measure

Primary outcomes

  1. Body Composition

    To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. Functional Improvements

    To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.

    Time frame: 8 weeks

07

Study locations

1 site
  • UCLA Center for Human Nutrition, 1000 Veteran Ave.
    Los Angeles, California 90095, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04350762
Lead sponsor
University of California, Los Angeles
Responsible party
Zhaoping Li (Chief / Professor of Medicine, University of California, Los Angeles) — Principal investigator
First posted
Apr 17, 2020
Start date
Sep 5, 2019
Primary completion
Sep 15, 2020
Completion
Dec 15, 2020
Last update
May 6, 2023

Study contacts

Zhaoping Li
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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