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Clinical Trials/NCT04350762
NCT04350762
Terminated
N/A

Nutritional Supplementation in the Elderly With Weight Loss

University of California, Los Angeles1 site in 1 country4 target enrollmentSeptember 5, 2019
ConditionsSarcopenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
University of California, Los Angeles
Enrollment
4
Locations
1
Primary Endpoint
Body Composition
Status
Terminated
Last Updated
2 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
September 5, 2019
End Date
December 15, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhaoping Li

Chief / Professor of Medicine

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Male or female age 65 and older
  • Non-smokers
  • Weight loss \>3% body weight over 6-12 months
  • 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,

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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