Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population

NCT01330550 | Unknown DMC

• 1 other identifier: DMR99-IRB-209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Keywords

High fiber sugar free biscuit; pre-diabetics

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The investigators expect the HbA1c will be greatly improved at the end of the study.

  up to 8 weeks

Secondary Outcomes (1)

• Insulin, Fasting Glucose,Ketone Body, Fructosamine.

  8 weeks

Study Arms (1)

high fiber sugar free biscuit.

EXPERIMENTAL

High fiber sugar free biscuit will regulate Blood sugars.

Dietary Supplement: High fiber sugar free biscuit

Interventions

High fiber sugar free biscuit DIETARY_SUPPLEMENT

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

Also known as: Taiwan IMeI high fiber sugar free biscuit

high fiber sugar free biscuit.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• DM patients
• Pregnant

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Huang Hui-Ying

CONTACT

886-4-22053366; <hyhuang@mail.cmu.edu.tw>

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: April 7, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 7, 2011

Record last verified: 2011-04

Locations

TW (1)