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

NCT ID: NCT02711839

Last Updated: 2019-07-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Commercial diabetic formula

Group Type PLACEBO_COMPARATOR

Commercial diabetic formula

Intervention Type DIETARY_SUPPLEMENT

The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation

Treatment Group

White sweet potato formula

Group Type EXPERIMENTAL

White sweet potato formula

Intervention Type DIETARY_SUPPLEMENT

The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation

Interventions

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Commercial diabetic formula

The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation

Intervention Type DIETARY_SUPPLEMENT

White sweet potato formula

The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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diabetic formula White sweet potato

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chih-Han Lin, MS

Role: PRINCIPAL_INVESTIGATOR

Office of Human Research, Taipei Medical University

References

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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.

Reference Type BACKGROUND
PMID: 24000051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31636690 (View on PubMed)

Other Identifiers

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201505027

Identifier Type: -

Identifier Source: org_study_id

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