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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: September 15, 2020
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).
- Dietary Supplement: Protein shake + Fish Oil
- 2 shakes of protein as well as 1 fish oil daily.
Arms, Groups and Cohorts
- Experimental: Supplement + Fish Oil
- 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 Intervention: Control
- No dietary supplements. Participants will continue current intake.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- Male or female age 65 and older
- Weight loss >3% body weight over 6-12 months
- BMI ≤ 25
- Living independently or in an assisted living facility
- 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
- 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
- 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
Gender Eligibility: All
Minimum Age: 65 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of California, Los Angeles
- Provider of Information About this Clinical Study
- Principal Investigator: Zhaoping Li, Chief / Professor of Medicine – University of California, Los Angeles
- Overall Official(s)
- Zhaoping Li, Principal Investigator, University of California, Los Angeles
- Overall Contact(s)
- Gail Thames, 310-825-0453, Gthames@mednet.ucla.edu
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