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

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02711839
Collaborator
(none)
54
Enrollment
2
Arms
16
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Commercial diabetic formula
  • Dietary Supplement: White sweet potato formula
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Office of Human Research, Taipei Medical University
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c After Intervention [60 days]

      HbA1c value after 60 days intervention in both groups

    Secondary Outcome Measures

    1. Albumin After Intervention [60 days]

      Albumin value after 60 days intervention in both groups

    2. Glucose After Intervention [60 days]

      Glucose value after 60 days intervention in both groups

    3. Total Cholesterol After Intervention [60 days]

      Total cholesterol value after 60 days intervention in both groups

    4. Triglyceride After Intervention [60 days]

      Triglyceride value after 60 days intervention in both groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Taipei Medical University

    Investigators

    • Principal Investigator: Chih-Han Lin, MS, Office of Human Research, Taipei Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT02711839
    Other Study ID Numbers:
    • 201505027
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Jul 1, 2019
    Last Verified:
    May 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Period Title: Overall Study
    STARTED 20 34
    COMPLETED 16 24
    NOT COMPLETED 4 10

    Baseline Characteristics

    Arm/Group Title Control Group Treatment Group Total
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation Total of all reporting groups
    Overall Participants 16 24 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    74.7
    (5.7)
    68.9
    (8.8)
    71.8
    (7.3)
    Sex: Female, Male (Count of Participants)
    Female
    8
    50%
    11
    45.8%
    19
    47.5%
    Male
    8
    50%
    13
    54.2%
    21
    52.5%

    Outcome Measures

    1. Primary Outcome
    Title HbA1c After Intervention
    Description HbA1c value after 60 days intervention in both groups
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Measure Participants 16 24
    Mean (Standard Deviation) [percentage]
    6.8
    (1.1)
    6.4
    (1.1)
    2. Secondary Outcome
    Title Albumin After Intervention
    Description Albumin value after 60 days intervention in both groups
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Measure Participants 16 24
    Mean (Standard Deviation) [g/dL]
    3.4
    (0.1)
    3.6
    (0.3)
    3. Secondary Outcome
    Title Glucose After Intervention
    Description Glucose value after 60 days intervention in both groups
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Measure Participants 16 24
    Mean (Standard Deviation) [mg/dL]
    126.7
    (38.9)
    131.0
    (45.4)
    4. Secondary Outcome
    Title Total Cholesterol After Intervention
    Description Total cholesterol value after 60 days intervention in both groups
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Measure Participants 16 24
    Mean (Standard Deviation) [mg/dL]
    180.0
    (53.6)
    150.1
    (25.7)
    5. Secondary Outcome
    Title Triglyceride After Intervention
    Description Triglyceride value after 60 days intervention in both groups
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    Measure Participants 16 24
    Mean (Standard Deviation) [mg/dL]
    214.3
    (112.2)
    145.4
    (59.3)

    Adverse Events

    Time Frame The adverse event data were collected from the participants during intervention and assessed after 6 months.
    Adverse Event Reporting Description No adverse event was happened in participants.
    Arm/Group Title Control Group Treatment Group
    Arm/Group Description Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
    All Cause Mortality
    Control Group Treatment Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/24 (0%)
    Serious Adverse Events
    Control Group Treatment Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/24 (0%)
    Other (Not Including Serious) Adverse Events
    Control Group Treatment Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/24 (0%)

    Limitations/Caveats

    Small experimental sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Sing-Chung Li
    Organization Taipei Medical University
    Phone 886-2-27361661 ext 6560
    Email sinchung@tmu.edu.tw
    Responsible Party:
    Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT02711839
    Other Study ID Numbers:
    • 201505027
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Jul 1, 2019
    Last Verified:
    May 1, 2015