Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

NCT02360722 | Withdrawn Phase 4

• 1 other identifier: BL26
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (1)

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

  24 weeks

Study Arms (2)

Oral Nutritional Supplement

EXPERIMENTAL

ONS + Nutritional education

Other: Oral Nutritional Supplement; Other: Nutritional Education

Control Group

OTHER

Nutritional education only

Other: Nutritional Education

Interventions

Oral Nutritional Supplement OTHER

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

Oral Nutritional Supplement

Nutritional Education OTHER

Two nutritional education courses at baseline and 3 months after intervention

Control Group; Oral Nutritional Supplement

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Xianfeng ZHAO, MD, PhD

  Abbott Nutrition R&D China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 11, 2015
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share