Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population

Study Overview
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Brief Summary
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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: Period-I: 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) The period-II: 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. Post-period: 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.

Detailed Description
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The increase in diabetic population of the world, is among the top ten causes of death; with diabetes always a top cause of death. Diabetes is always related with other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease). The eating habits and patterns of diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber rand 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: Period-I: 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) Blood samples will be collected from all 60 subjects to investigate: HbA1c, Blood sugars(Fasting and 2 hours after meal), Insulin, Fructosamine, SGOT,SGPT,ALK-P,TOTAL PROTEIN, Albumin, Globulin, Ketone, Bun,Creatinine, Cholesterol,TG,LDl,HDL, WBC,RBC,Hgb,Hct,M.C.V.,MCH,MCHC,Platelet. The period-II: Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group), All 30 subjects consume 3 serving 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. Post-period: 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.

Official Title
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Effect of High Fiber and Sugar Free Biscuits in Diabetics Population

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Dietary Supplement: High fiber sugar free biscuit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fasting blood glucose ≧100mg/dL and < 126mg/dL Impaired glucose tolerance; IGT HbA1c < 9% Exclusion Criteria: DM patients Pregnant

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high fiber sugar free biscuit.<br>High fiber sugar free biscuit will regulate Blood sugars. | Dietary Supplement: High fiber sugar free biscuit<br>* Dosage form:Biscuit, Dosage:1.94gram fiber/slice, Frequency:9 slices/meal;3 times/day. Duration:8 weeks<br>* Other names: Taiwan IMeI high fiber sugar free biscuit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The investigators expect the HbA1c will be greatly improved at the end of the study. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin, Fasting Glucose,Ketone Body, Fructosamine. | The investigators expect the following data will be improved at the end of the study:Insulin, Fasting Glucose, Ketone Body, Fructosamine. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High fiber sugar free biscuit, pre-diabetics