Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly

NCT01261663

Malnutrition in the Elderly

COMPLETED

Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk

NCT06062914

Malnutrition Nutritional Risk

UNKNOWN

A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment

NCT02698540

Malnutrition

COMPLETED

Effective Consumption of Oral Nutritional Supplements in Geriatrics: A Study Evaluating a Strategy Based on a Preliminary Degustation

NCT02857049

Malnutrition Geriatric Patients

UNKNOWN NA

Nutrition to Support Postoperative Recovery

NCT07109505

Postoperative Care Postoperative Complications Cognition +2 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition Muscle Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ONS1

new product

Group Type EXPERIMENTAL

ONS

Intervention Type DIETARY_SUPPLEMENT

randomized clinical trial involving different ONS strategies

ONS2

usual care

Group Type ACTIVE_COMPARATOR

ONS

Intervention Type DIETARY_SUPPLEMENT

randomized clinical trial involving different ONS strategies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ONS

randomized clinical trial involving different ONS strategies

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 65+
* at risk of malnutrition/ malnourished

Exclusion Criteria

* • Mental status that is incompatible with the proper conduct of the study

* Illness of such severity that life expectancy is considered to be less than 12 months
* Use of diabetes medication (e.g. insulin, methformin)
* Use of an oral nutritional supplement in the previous three months
* Participating in any regular exercise training program (≥2h/w)
* Renal insufficiency (eGFR \<30 mL/min/1.73 m2)
* Unstable organ failure or organ failure necessitating a special diet
* Chronic corticosteroids use
* Recent (previous 2 months) use of antibiotics
* Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
* Recent blood donation (\<1 month prior to Day 01 of the study)
* Not willing or afraid to give blood during the study
* Allergic or sensitive for milk proteins
* Reported vegan or macrobiotic life-style
* Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
* Individual unable to give informed consent
* Current participation in other research from the Division of Human Nutrition
* Not having a general practitioner
* Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes