Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population
Recruitment status was: Recruiting
The increase in diabetic population of the world is among the top ten causes of death; with diabetes always high on the list of causes of death. Diabetes is always relative to other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease).
The eating habits and patterns of the diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber and low sugar dietary intake can significantly reduce the incidence of diabetes.
The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in regulating blood glucose in pre-diabetic subjects.
The study will be conducted in three periods:
The recruitment of 60 pre-diabetic subjects:
Subjects of blood glucose levels "Impaired fasting glucose; IFG": fasting blood glucose ≧ 100 mg / dL, < 126 mg / dL or "Impaired glucose tolerance; IGT": 2 hours postprandial blood glucose ≧ 140mg/dL, < 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus (HbA1c < 9%).
In addition to perform pre-test, all subjects also need to complete nutrition counseling and nutrition education .
All 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group)
Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.
Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30 subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of fiber) daily.
Blood samples of all 60 subjects will be collected to compare with period-I and period-II at the first day of 9th week.
Report of expectation:
The purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
|Official Title:||Effect of High Fiber and Sugar Free Biscuits in Diabetics Population|
- HbA1c [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]The investigators expect the HbA1c will be greatly improved at the end of the study.
- Insulin, Fasting Glucose,Ketone Body, Fructosamine. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]The investigators expect the following data will be improved at the end of the study:Insulin, Fasting Glucose, Ketone Body, Fructosamine.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: high fiber sugar free biscuit.
High fiber sugar free biscuit will regulate Blood sugars.
Dietary Supplement: High fiber sugar free biscuit
Dosage form:Biscuit, Dosage:1.94gram fiber/slice, Frequency:9 slices/meal;3 times/day. Duration:8 weeks
Other Name: Taiwan IMeI high fiber sugar free biscuit
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01330550
|China Medical University|
|Taichung, Taiwan, 404|