Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population

Impaired Glucose Tolerance Clinical Trial

Official title:

Effect of High Fiber and Sugar Free Biscuits in Diabetics Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01330550
• Other study ID #: DMR99-IRB-209
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2011
• Last updated: April 6, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: China Medical University Hospital
• Contact: Huang Hui-Ying
• Phone: 886-4-22053366
• Email: [@]mail.cmu.edu.tw>
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• fasting blood glucose ?100mg/dL and < 126mg/dL

• Impaired glucose tolerance; IGT

• HbA1c < 9%

Exclusion Criteria:

• DM patients

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	The investigators expect the HbA1c will be greatly improved at the end of the study.	up to 8 weeks	Yes
Secondary	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	Yes