Nutritional Supplementation in the Elderly With Weight Loss (Elderly)

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.

Study Overview

• Status: Terminated
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Protein shake + Fish Oil

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.	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.	8 weeks
Functional Improvements	To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.	8 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Zhaoping Li, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; protein supplementation; unintentional weight loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Muscular Atrophy; Atrophy; Weight Loss; Sarcopenia
• Other Study ID Numbers: 18-001995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No