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Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population

Effect of High Fiber and Sugar Free Biscuits in Diabetics Population

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01330550
Enrollment
60
Registered
2011-04-07
Start date
2011-03-31
Completion date
2011-12-31
Last updated
2011-04-07

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

Conditions

Impaired Glucose Tolerance

Keywords

High fiber sugar free biscuit, pre-diabetics

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTHigh fiber sugar free biscuit

Dosage form:Biscuit, Dosage:1.94gram fiber/slice, Frequency:9 slices/meal;3 times/day. Duration:8 weeks

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* fasting blood glucose ≧100mg/dL and \< 126mg/dL * Impaired glucose tolerance; IGT * HbA1c \< 9%

Exclusion criteria

* DM patients * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
HbA1cup to 8 weeksThe investigators expect the HbA1c will be greatly improved at the end of the study.

Secondary

MeasureTime frameDescription
Insulin, Fasting Glucose,Ketone Body, Fructosamine.8 weeksThe investigators expect the following data will be improved at the end of the study:Insulin, Fasting Glucose, Ketone Body, Fructosamine.

Countries

Taiwan

Contacts

Primary ContactHuang Hui-Ying
<hyhuang@mail.cmu.edu.tw>886-4-22053366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026