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Nutritional Supplementation in the Elderly With Weight Loss (Elderly)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350762
Recruitment Status : Terminated (Unable to enroll due to Pandemic)
First Posted : April 17, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

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 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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Protein shake + Fish Oil Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Nutritional Supplementation in the Elderly With Weight Loss
Actual Study Start Date : September 5, 2019
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
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
2 shakes of protein as well as 1 fish oil daily.

No Intervention: Control
No dietary supplements. Participants will continue current intake.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350762


Locations
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United States, California
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li University of California, Los Angeles
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Responsible Party: Zhaoping Li, Chief / Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04350762    
Other Study ID Numbers: 18-001995
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
Elderly
protein supplementation
unintentional weight loss
Additional relevant MeSH terms:
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Sarcopenia
Weight Loss
Body Weight Changes
Body Weight
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical