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Nutritional Supplementation in the Elderly With Weight Loss (Elderly)

Primary Purpose

Sarcopenia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Protein shake + Fish Oil

About this trial

This is an interventional other trial for Sarcopenia focused on measuring Elderly, protein supplementation, unintentional weight loss

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supplement + Fish Oil

Control

Arm Description

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).

No dietary supplements. Participants will continue current intake.

Outcomes

Primary Outcome Measures

Body Composition

To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.

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.

Functional Improvements

To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.

Secondary Outcome Measures

Full Information

NCT ID

NCT04350762

First Posted

April 10, 2020

Last Updated

May 4, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04350762

Brief Title

Nutritional Supplementation in the Elderly With Weight Loss

Acronym

Elderly

Official Title

Nutritional Supplementation in the Elderly With Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Unable to enroll due to Pandemic

Study Start Date

September 5, 2019 (Actual)

Primary Completion Date

September 15, 2020 (Actual)

Study Completion Date

December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

Keywords

Elderly, protein supplementation, unintentional weight loss

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supplement + Fish Oil

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

No dietary supplements. Participants will continue current intake.

Intervention Type

Dietary Supplement

Intervention Name(s)

Protein shake + Fish Oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Body Composition

Description

To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.

Time Frame

8 weeks

Title

Nutritional Status

Description

Time Frame

8 weeks

Title

Functional Improvements

Description

To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Center for Human Nutrition, 1000 Veteran Ave.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Nutritional Supplementation in the Elderly With Weight Loss

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