Replace Glycemic Load and Satiety Study

Study Overview
=================
Brief Summary
-----------------
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

Detailed Description
-----------------
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.

Official Title
-----------------
Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1

Conditions
-----------------
Glucose Blood, Glycemic Index

Intervention / Treatment
-----------------
* Other: High GL 107
* Other: Medium GL 76
* Other: Medium GL 68
* Other: Low GL 48


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass index between 25-35 kg/m2 Fasting serum glucose Fasting serum glucose < 125 mg/dl Free of chronic disease Willing to eat only the foods that are provided by the Center during the diet periods Willing to abstain from the consumption of alcohol during the diet periods Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile Monophasic birth control (same dose each day) Hormone replacement therapy Post-menopausal (over 1 year without bleeding) Have had partial hysterectomy over the age of 55 complete hysterectomy at any age Exclusion Criteria: Documented presence of atherosclerotic disease Diabetes mellitus Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease Body Mass Index <25 or > 35 History of drug or alcohol abuse in the last year For women, pregnancy, breast feeding or postpartum < 6 months History of depression or mental illness requiring treatment or medication within that last 6 months Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence Lifestyle or schedule incompatible with the study protocol Planned continued use of dietary supplements through the study trial Smoking or tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet 1<br>High GI; High Carb; High GL | Other: High GL 107<br>* Three meals a day<br>|
| Experimental: Diet 2<br>High GI, Low Carb, Med GL | Other: Medium GL 76<br>* Three meals a day<br>|
| Experimental: Diet 3<br>Low GI, High Carb, Med GL | Other: Medium GL 68<br>* Three meals a day<br>|
| Experimental: Diet 4<br>Low GI, Low Carb, Low GL | Other: Low GL 48<br>* Three meals a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose over time | Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog scores (VAS) | Hunger, satiety, and vigor will be measured by the visual analog scales. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycemic Index