Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions

Office of Human Research, Taipei Medical University

In order to response the increasing of aging population cause losing ability that need long-care needs, the project entitled "10-year long-term care program" from Executive Yuan in 2007 is carried out to assist economically disadvantaged and disabled elderly to acquire daily nutrition. Therefore, the long-term care resident's nutritional status got more attention than before. Out of control in blood glucose will not only increase bed sores and urinary tract infection in tube feeding residents but also rise medical expenditures. The nutritional status of long-term care institutions, anyang homes and nursing home are generally bad in nutrition management due to high cost of nutritional supplements from foreign imports that cause the burden of families. In this study, we will recruit diabetic subjects that divide into white sweet potato group (experimental group) and commercial formula group (control group) by using randomized, parallel and open clinical study through tube feeding in sixty days.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Commercial diabetic formula; Dietary supplement: White sweet potato formula

Detailed Description

All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Long-term stability nasogastric or gastrostomy-fed person.
• The physician diagnosed as diabetic and regular use of hypoglycemic drugs.

Exclusion Criteria:

• Psychosis or depression.
• Hba1c> 8.5%.
• High taking nutritional supplements or steroids drugs.
• Have undergone abdominal surgery caused by intestinal sticky.
• Suffering from cancer, ulcers, respiratory infections and other diseases.
• Currently receiving central venous nutrition therapy or intravenous nutrition therapy.
• Liver dysfunction (ALT ≧ 100 U / L), renal insufficiency (creatinine ≧ 3mg / dl), heart failure (NYFc II above), moderate anemia (hemoglobin <9 g / dl).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Commercial diabetic formula	Dietary supplement: Commercial diabetic formula; The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation; Other Names: diabetic formula
Experimental: Treatment Group; White sweet potato formula	Dietary supplement: White sweet potato formula; The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation; Other Names: White sweet potato

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c After Intervention	HbA1c value after 60 days intervention in both groups	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin After Intervention	Albumin value after 60 days intervention in both groups	60 days
Glucose After Intervention	Glucose value after 60 days intervention in both groups	60 days
Total Cholesterol After Intervention	Total cholesterol value after 60 days intervention in both groups	60 days
Triglyceride After Intervention	Triglyceride value after 60 days intervention in both groups	60 days

Collaborators and Investigators

• Sponsor: Taipei Medical University

Publications and helpful links

General Publications

• Ooi CP, Loke SC. Sweet potato for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2013 Sep 3;2013(9):CD009128. doi: 10.1002/14651858.CD009128.pub3.
• Chen CM, Shih CK, Su YJ, Cheang KU, Lo SF, Li SC. Evaluation of white sweet potato tube-feeding formula in elderly diabetic patients: a randomized controlled trial. Nutr Metab (Lond). 2019 Oct 16;16:70. doi: 10.1186/s12986-019-0398-8. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: March 13, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 201505027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No