Impaired Glucose Tolerance Clinical Trial
Official title:
Effect of High Fiber and Sugar Free Biscuits in Diabetics Population
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
| Completed |
NCT04088461 -
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine
|
Phase 4 | |
| Completed |
NCT02621060 -
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
|
Phase 2 | |
| Completed |
NCT01488279 -
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
|
N/A | |
| Completed |
NCT01521312 -
ACute and Chronic Effects of Saxagliptin
|
Phase 2 | |
| Completed |
NCT01559896 -
Egg Protein Hydrolysate and Vascular Function
|
N/A | |
| Completed |
NCT01030978 -
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
|
N/A | |
| Completed |
NCT00573781 -
Dietary Modulation of Gene Expression and Metabolic Pathways in Glucose Metabolism
|
Phase 2 | |
| Terminated |
NCT00846521 -
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
|
Phase 4 | |
| Completed |
NCT00241072 -
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance
|
Phase 4 | |
| Completed |
NCT00536250 -
Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth
|
N/A | |
| Completed |
NCT02254317 -
Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance
|
N/A | |
| Completed |
NCT03764423 -
Health Effects of Salmon Fishmeal in Humans
|
N/A | |
| Recruiting |
NCT05347030 -
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
|
N/A | |
| Active, not recruiting |
NCT04341571 -
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
|
Phase 2 | |
| Completed |
NCT02700334 -
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
|
Phase 4 | |
| Active, not recruiting |
NCT01933529 -
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
|
Phase 2 | |
| Completed |
NCT02135172 -
Breaks in Sedentary Time and Glucose Regulation in Women
|
N/A | |
| Active, not recruiting |
NCT01841229 -
Effect of Ginseng on Glycemic Control
|
N/A | |
| Completed |
NCT02248272 -
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes
|
N/A |