Nutritional Supplementation in the Elderly With Weight Loss

Sarcopenia Clinical Trial

— Elderly  

Official title:

Nutritional Supplementation in the Elderly With Weight Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04350762
• Other study ID #: 18-001995
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Weight Loss

Intervention

Dietary Supplement:
• Protein shake + Fish Oil
2 shakes of protein as well as 1 fish oil daily.

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition, 1000 Veteran Ave.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Functional Improvements	To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.	8 weeks