NCT05609006

Brief Summary

This study aims to investigate the compliance of high-energy, low-volume oral nutritional supplements (ONS) compared to equivalent high-energy standard ONS (control) in participants at risk of malnutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2.5 years

First QC Date

October 31, 2022

Last Update Submit

November 4, 2022

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Compliance rate with ONS

    Percentage of consumed energy over the prescribed

    One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)

Secondary Outcomes (2)

  • Gastrointestinal tolerance

    Weekly (from second to fourth week of each period) up to 8 weeks

  • Satisfaction with ONS

    For each period/ONS, up to 8 weeks

Study Arms (2)

Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS

EXPERIMENTAL

Intervention: high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days followed by high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days

Dietary Supplement: High-Energy, Low-Volume ONSDietary Supplement: High-Energy Standard ONS

Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS

EXPERIMENTAL

Intervention: high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days followed by high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days

Dietary Supplement: High-Energy, Low-Volume ONSDietary Supplement: High-Energy Standard ONS

Interventions

High-Energy, Low-Volume ONSDIETARY_SUPPLEMENT

2 bottles/day of a High-Energy, Low-Volume ONS

Also known as: Energy-dense ONS, 2.4 ONS
Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONSGroup B: High-Energy Standard ONS // High-Energy, Low-Volume ONS
High-Energy Standard ONSDIETARY_SUPPLEMENT

2 bottles/day of a High-Energy Standard ONS

Also known as: 2.0 ONS
Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONSGroup B: High-Energy Standard ONS // High-Energy, Low-Volume ONS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years
  • Patients with malnutrition or at risk of malnutrition according to Subjective Global Assessment (SGA).
  • Patients with a high energy requirement that require 2 bottles/day of an ONS (≥2kcal/ml), for a minimum period of 8 weeks
  • Patients who voluntarily agree to participate in the study and give their signed consent for participation.

You may not qualify if:

  • Patients suffering from any of the following clinical disorders: chronic kidney insufficiency or diabetes.
  • Patients requiring enteral tube feeding or parenteral nutrition.
  • Patients suffering from an allergy or intolerance to the product ingredients.
  • Patients scheduled for surgery during the study period.
  • Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29001, Spain

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Miguel Leon, MD

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

  • Gabriel Olveira, MD

    Hospital Regional de Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 8, 2022

Study Start

July 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)