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Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

Primary Purpose

Malnutrition

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Oral Nutritional Supplement

Nutritional Education

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female Chinese ages >= 60 years.
Subject is ambulatory.
Subject with risks of malnutrition defined as DETERMINE score >=3
Subject's BMI is below 28.
Subject has experienced hospital stay or surgery within 6 months prior to enrollment;
Subject if takes any medications for concomitant chronic diseases should be in stable dosage for at least 3 weeks.
Subject plans to live in the community for more than 6 months after recruitment.
Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

Subject has history of allergy to any ingredient in the study product
Subject dislikes the experimental product
Subject has been diagnosed with diabetes.
Subject who has malignancy expected to receive chemotherapy/ radiotherapy scheduled during the study period,
Subject has a life expectancy less than 6 months.
Subject who has reported chronic liver disease or liver cirrhosis or liver failure or any liver diseases not suitable for the study as the study physician's opinion.
Subject who has reported impacted renal function as eGFR < 30 mL/min/1.73 m2 or renal dysfunction severe greater than stage 4 or any other renal diseases not suitable for the study as the study physician' s opinion.
Subject who has experienced fever or diarrhea within one week prior to enrollment.
Subject who is expected to have scheduled major surgery during the study period.
Subject who has physical disabilities such as loss of hand or foot or limbs or any other physical disability which may affect the muscle mass measurement by the opinion of the study physician.
Subject has an implanted electronic device or orthopedic metal implantations, such as pacemaker, cardiac defibrillator, subcutaneous injection pump, or metal hip, metal knee joint, metal fracture internal fixation, etc.
Subject who has active tuberculosis (TB), hepatitis, or HIV infection as self-reported at enrollment.
Subject has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
Subject is drug addicted or alcohol addicted
Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians.
Subject is participating in other clinical trials which are not approved by AN

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Oral Nutritional Supplement

Control Group

Arm Description

ONS + Nutritional education

Nutritional education only

Outcomes

Primary Outcome Measures

Change of body weight from baseline to the end of the study

Secondary Outcome Measures

Total number of sick days due to Upper Respiratory Tract Infections (URTI)

Full Information

NCT ID

NCT02360722

First Posted

January 27, 2015

Last Updated

November 30, 2016

Sponsor

Abbott Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT02360722

Brief Title

Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

Official Title

Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Why Stopped

The study was cancelled due to change in food registration regulations in China.

Study Start Date

October 2016 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single- country, interventional, double-arm study involving Chinese Elderly subjects.

Detailed Description

This study aims to understand the following: The effect of long-term Oral Nutritional Supplementation (ONS) on improving nutritional and health status in Chinese elderly. The impact of long-term ONS on health cost including both medical cost and social health care burdens. The impact of long-term ONS on life quality of the elderly. The study includes Screening Visit (Day -7~0), and Visit 1(Day 0) to Visit 7 (Day 168±3). Enrollment of anticipated 666 subjects, Male or female Chinese ages >= 60 years, to get 400 evaluable subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Nutritional Supplement

Arm Type

Experimental

Arm Description

ONS + Nutritional education

Arm Title

Control Group

Arm Type

Other

Arm Description

Nutritional education only

Intervention Type

Other

Intervention Name(s)

Oral Nutritional Supplement

Intervention Description

Will receive ONS twice a day for 6 months and two nutritional education at baseline and 3 months after intervention

Intervention Type

Other

Intervention Name(s)

Nutritional Education

Intervention Description

Two nutritional education courses at baseline and 3 months after intervention

Primary Outcome Measure Information:

Title

Change of body weight from baseline to the end of the study

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Total number of sick days due to Upper Respiratory Tract Infections (URTI)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Chinese ages >= 60 years. Subject is ambulatory. Subject with risks of malnutrition defined as DETERMINE score >=3 Subject's BMI is below 28. Subject has experienced hospital stay or surgery within 6 months prior to enrollment; Subject if takes any medications for concomitant chronic diseases should be in stable dosage for at least 3 weeks. Subject plans to live in the community for more than 6 months after recruitment. Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study. Exclusion Criteria: Subject has history of allergy to any ingredient in the study product Subject dislikes the experimental product Subject has been diagnosed with diabetes. Subject who has malignancy expected to receive chemotherapy/ radiotherapy scheduled during the study period, Subject has a life expectancy less than 6 months. Subject who has reported chronic liver disease or liver cirrhosis or liver failure or any liver diseases not suitable for the study as the study physician's opinion. Subject who has reported impacted renal function as eGFR < 30 mL/min/1.73 m2 or renal dysfunction severe greater than stage 4 or any other renal diseases not suitable for the study as the study physician' s opinion. Subject who has experienced fever or diarrhea within one week prior to enrollment. Subject who is expected to have scheduled major surgery during the study period. Subject who has physical disabilities such as loss of hand or foot or limbs or any other physical disability which may affect the muscle mass measurement by the opinion of the study physician. Subject has an implanted electronic device or orthopedic metal implantations, such as pacemaker, cardiac defibrillator, subcutaneous injection pump, or metal hip, metal knee joint, metal fracture internal fixation, etc. Subject who has active tuberculosis (TB), hepatitis, or HIV infection as self-reported at enrollment. Subject has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician. Subject is drug addicted or alcohol addicted Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians. Subject is participating in other clinical trials which are not approved by AN

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianfeng ZHAO, MD, PhD

Organizational Affiliation

Abbott Nutrition R&D China

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

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Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

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