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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02711839
Enrollment
54
Registered
2016-03-17
Start date
2015-08-31
Completion date
2016-12-31
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTCommercial diabetic formula

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

DIETARY_SUPPLEMENTWhite sweet potato formula

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

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
HbA1c After Intervention60 daysHbA1c value after 60 days intervention in both groups

Secondary

MeasureTime frameDescription
Albumin After Intervention60 daysAlbumin value after 60 days intervention in both groups
Glucose After Intervention60 daysGlucose value after 60 days intervention in both groups
Total Cholesterol After Intervention60 daysTotal cholesterol value after 60 days intervention in both groups
Triglyceride After Intervention60 daysTriglyceride value after 60 days intervention in both groups

Participant flow

Participants by arm

ArmCount
Control Group
Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\ 1800 kcal daily depend on the patient's individual situation
16
Treatment Group
White sweet potato formula White sweet potato formula: The formula were supplied 1500\ 1800 kcal daily depend on the patient's individual situation
24
Total40

Baseline characteristics

CharacteristicControl GroupTreatment GroupTotal
Age, Continuous74.7 years
STANDARD_DEVIATION 5.7
68.9 years
STANDARD_DEVIATION 8.8
71.8 years
STANDARD_DEVIATION 7.3
Sex: Female, Male
Female
8 Participants11 Participants19 Participants
Sex: Female, Male
Male
8 Participants13 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 24
other
Total, other adverse events
0 / 160 / 24
serious
Total, serious adverse events
0 / 160 / 24

Outcome results

Primary

HbA1c After Intervention

HbA1c value after 60 days intervention in both groups

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Control GroupHbA1c After Intervention6.8 percentageStandard Deviation 1.1
Treatment GroupHbA1c After Intervention6.4 percentageStandard Deviation 1.1
Secondary

Albumin After Intervention

Albumin value after 60 days intervention in both groups

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Control GroupAlbumin After Intervention3.4 g/dLStandard Deviation 0.1
Treatment GroupAlbumin After Intervention3.6 g/dLStandard Deviation 0.3
Secondary

Glucose After Intervention

Glucose value after 60 days intervention in both groups

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Control GroupGlucose After Intervention126.7 mg/dLStandard Deviation 38.9
Treatment GroupGlucose After Intervention131.0 mg/dLStandard Deviation 45.4
Secondary

Total Cholesterol After Intervention

Total cholesterol value after 60 days intervention in both groups

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Cholesterol After Intervention180.0 mg/dLStandard Deviation 53.6
Treatment GroupTotal Cholesterol After Intervention150.1 mg/dLStandard Deviation 25.7
Secondary

Triglyceride After Intervention

Triglyceride value after 60 days intervention in both groups

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Control GroupTriglyceride After Intervention214.3 mg/dLStandard Deviation 112.2
Treatment GroupTriglyceride After Intervention145.4 mg/dLStandard Deviation 59.3

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026