Clinical trial: Nutritional Supplementation in the Elderly With Weight Loss (NCT04350762)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction