Nutritional Supplementation in the Elderly With Weight Loss

NCT04350762 | Terminated

• 1 other identifier: 18-001995
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Elderly; protein supplementation; unintentional weight loss

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Supplement + Fish Oil

EXPERIMENTAL

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

Control

NO INTERVENTION

No dietary supplements. Participants will continue current intake.

Interventions

Protein shake + Fish Oil DIETARY_SUPPLEMENT

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

Supplement + Fish Oil

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Zhaoping Li

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief / Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: September 5, 2019
• Primary Completion: September 15, 2020
• Study Completion: December 15, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)