Nutritional Supplementation in the Elderly With Weight Loss

Study Overview
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Brief Summary
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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
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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).

Official Title
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Nutritional Supplementation in the Elderly With Weight Loss

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Protein shake + Fish Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement + Fish Oil<br>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<br>* 2 shakes of protein as well as 1 fish oil daily.<br>|
| No Intervention: Control<br>No dietary supplements. Participants will continue current intake. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, protein supplementation, unintentional weight loss