Trial Outcomes & Findings for Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions (NCT NCT02711839)

Results Overview

HbA1c value after 60 days intervention in both groups

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

60 days

Results posted on

2019-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	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
Overall Study STARTED	20	34
Overall Study COMPLETED	16	24
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Total n=40 Participants Total of all reporting groups
Age, Continuous	74.7 years STANDARD_DEVIATION 5.7 • n=5 Participants	68.9 years STANDARD_DEVIATION 8.8 • n=7 Participants	71.8 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

HbA1c value after 60 days intervention in both groups

Outcome measures

Outcome measures
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation
HbA1c After Intervention	6.8 percentage Standard Deviation 1.1	6.4 percentage Standard Deviation 1.1

SECONDARY outcome

Timeframe: 60 days

Albumin value after 60 days intervention in both groups

Outcome measures

Outcome measures
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation
Albumin After Intervention	3.4 g/dL Standard Deviation 0.1	3.6 g/dL Standard Deviation 0.3

SECONDARY outcome

Timeframe: 60 days

Glucose value after 60 days intervention in both groups

Outcome measures

Outcome measures
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation
Glucose After Intervention	126.7 mg/dL Standard Deviation 38.9	131.0 mg/dL Standard Deviation 45.4

SECONDARY outcome

Timeframe: 60 days

Total cholesterol value after 60 days intervention in both groups

Outcome measures

Outcome measures
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation
Total Cholesterol After Intervention	180.0 mg/dL Standard Deviation 53.6	150.1 mg/dL Standard Deviation 25.7

SECONDARY outcome

Timeframe: 60 days

Triglyceride value after 60 days intervention in both groups

Outcome measures

Outcome measures
Measure	Control Group n=16 Participants Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation	Treatment Group n=24 Participants White sweet potato formula White sweet potato formula: The formula were supplied 1500\~1800 kcal daily depend on the patient's individual situation
Triglyceride After Intervention	214.3 mg/dL Standard Deviation 112.2	145.4 mg/dL Standard Deviation 59.3

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sing-Chung Li

Taipei Medical University

Phone: 886-2-27361661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place