Clinical trial NCT04350762: Nutritional Supplementation in the Elderly With Weight Loss
Official title: Nutritional Supplementation in the Elderly With Weight Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcopenia
Keywords: Elderly
protein supplementation
unintentional weight loss
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility 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

Primary outcomes:
measure: Body Composition
timeFrame: 8 weeks
measure: Nutritional Status
timeFrame: 8 weeks
measure: Functional Improvements
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, 1000 Veteran Ave.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li
role: PRINCIPAL_INVESTIGATOR
References: