Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01330550
First received: March 9, 2011
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Impaired Glucose Tolerance
Dietary Supplement: High fiber sugar free biscuit

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • DM patients
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330550

Contacts
Contact: Huang Hui-Ying 886-4-22053366 ext 7506 <hyhuang@mail.cmu.edu.tw>

Locations
Taiwan
China Medical University Recruiting
Taichung, Taiwan, 404
Contact: Huang Hui-Ying    886-4-22053366 ext 7506    hyhuang@mail.cmu.edu.tw   
Sponsors and Collaborators
China Medical University Hospital
  More Information

No publications provided

Responsible Party: Hui-Ying, Huang/associate professor, China Medical University
ClinicalTrials.gov Identifier: NCT01330550     History of Changes
Other Study ID Numbers: DMR99-IRB-209
Study First Received: March 9, 2011
Last Updated: April 6, 2011
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by China Medical University Hospital:
High fiber sugar free biscuit
pre-diabetics

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014