Study 3    

Open for participation for diabetics and their educators

The effect of Low Glycemic Foods on Blood Glucose in Type 1 and Type 2 patients with diabetes.

Principal Investigator:              Steve Freed, RPh, Diabetes Educator

                                                DiabetesInControl.com

                                                Deerfield, IL 60006

800-798-6972

Registration: Begins NOW

Start: January 20-30, 2001

End: May 2001

THE STUDY:

The Logic Nutrition Program incorporates the use of low glycemic carbohydrates that help stabilize blood sugar levels, reduce body fat and insulin resistance. The program eliminates high glycemic carbohydrates, too much protein and too much fat, all of which help create blood sugar spikes and the resultant insulin response.

The ratio of carbohydrates to protein to fat is a key factor in putting the body into true balance. The 50-25-25 ratio found in the Logic Nutrition Program promotes increased energy, balance, fat burning, recovery, mental clarity and hormonal function. Too many carbohydrates spike your blood sugar, leading to increased fat storage, and pancreatic insulin response that can over time create hyperinsulinemia and insulin resistance which can increase your risk for cardiovascular disease.

Anecdotal results have shown type 1 diabetics lower their insulin needs and type 2 diabetics have been able to achieve normal ranges.

The 50-25-25 ratio in the program is designed to give the type 1 or type 2 diabetic the correct amount of fat protein and carbohydrates to allow glucose control without unwanted side effects.

We know that too few carbohydrates deplete your energy and have a catabolic muscle wasting effect. Too much protein puts a strain on the kidneys and increases acidity levels in the body, while too little protein depletes brain, liver, organ and muscle tissue. The wrong type of fat is damaging to your cells, while the right type of fat not only builds a healthy cell wall, but also increases the metabolism while optimizing hormonal function.

The goal of the Logic Nutrition Program is to maximize the body's muscle functions and minimize and possibly reverse insulin resistance. This program can also be beta cell sparing by reducing the workload on the pancreas.

The Logic Nutrition  Program incorporates a low glycemic, nutrient dense, balanced approach to eating and supplementing. The program provides your patient with a meal plan that introduces foods and supplements in the specific ratios of high quality protein, low glycemic carbohydrates and essential fats. You can also select foods you enjoy within each of these categories from an approved list that is provided within the Logic System section, as well as by way of the low glycemic index chart.  

To help you personalize the Logic Nutrition Program,  a manual with a set of optimal meal plans is provided. These meal plans are the perfect way to instill the core principles and habits of macro-nutrient rich, low glycemic eating. 

The first step before making use of our meal plans is to determine the daily protein requirement.  A formula will be provided so you will be able to calculate your protein requirement and then you will be able to select the meal plan that is best suited. 

This determination of your protein requirement is based on a combination of your lean body mass (how much you weigh without fat) and activity level 

 The Logic Nutrition Program is designed to:

Stabilize blood sugar

Control insulin levels

Burn body fat

Build lean muscle

Increase energy

 Fight free-radicals

Lower LDL cholesterol 

Raise HDL cholesterol  

 

BONUS STUDY ARM

Introduction: :  WALK A MILE IN YOUR PATIENT’S SHOES! 

How would you like to have an opportunity to walk a mile in your patient's shoes?

We have arranged with Logic Nutrition a unique opportunity.  Logic Nutrition will supply at no charge, the complete Logic Nutrition Program that includes a 3-month supply of their meals and nutritionals to any educator who would like to experience the program along with their patients.

This is a real chance to set an example for your patients. To often we are perceived as a "do as I say not as I do" profession and our patients often wonder if we could adhere to the rules we set for them.

You and your selected patients would be able to experience this together and realize the benefits of the program.

Low glycemic nutrition means high performance energy without the sugar.  Low glycemic nutrition is premium fuel for athletes, increasing endurance and stamina by as much as 60%.  Low glycemic nutrition limits fat storage, increases fat oxidation and has been shown to reduce hunger by 83%.  A low glycemic diet has been shown to reduce the incidence of heart attach by 50% and level blood sugars which can lower the risk for diabetes.

TRIAL DESIGN:

60 diabetic patients and 20 diabetes medical professionals will be supplied with a complete nutritional program with a meal plan and 2 of the 5 meals a day.  These 2 meals will consist of 1 great tasting bar and 1 shake.  They will also be supplied with vitamin and mineral supplements.  The Study will last for 90 days.  The value of the program for 3 months is over 1200 dollars which will be at no cost to you or the patient.  Because of the cost of the program, we would like to use patients that will be compliant with all the aspects of the program. The educator and patient will be supplied with a brief manual and CD explaining the program, fat calibers for the educator and a help desk for any questions from educators or patients.

There will be 3 arms to the study:  The choice will be at random

Participants will be provided individual meal plans + meal replacement bars + shakes

Individual meal plans + meal replacement bars + shakes + adaptapower

Individual meal plans + meal replacement bars + shakes + adaptapower + msm + efas + am/pm multi vitamin-mineral-herbs 

20 Diabetes Educators will also be supplied the complete nutritional program as above.  For the educators, (arm #3) we will monitor the same outcomes if diabetic, if not diabetic we will monitor blood pressure, weight, cholesterol and body fat. 

EFFICACY VARIABLES

1. Hemoglobin A₁c

2. Fasting Blood Glucose

3. PostPrandial Blood Glucose

4. Blood Pressure

5. Body Weight

6. Body Fat

7. Cholesterol Levels

STUDY PROCEDURES

Preliminary:  One week prior to the first visit, the patient will monitor their fasting and 2 hour postprandial blood glucose once daily for 5 out of 7 days.

Visit 1:

The patient will meet with the educator at the beginning of the study and the information necessary will be collected and a questionnaire will be filled out with the educator.  A daily fasting and postprandial blood glucose will be required by the patient during the length of the study.  Starting readings will be collected and recorded, HbA1c, BP, Body fat, Weight, and Cholesterol levels.   One month of supplies will be given to the patient at the first meeting.  

Phone call 1:

A call will be made to the patient 4-5 days after starting to answer questions and insure compliance.

Visit 2:

The patient will come in for another visit in 30 days so they can receive the next 30 day supply of products and BP, weight, body fat will be measured,  the fasting and postprandial blood glucose values will be collected and an average will be reported and faxed in, the forms will be supplied.  Then the next 30 days of supplies will be given to the patient. 

Visit 3:

The third visit will be the same as the second.  Wt, body fat,  blood pressure, fasting and postprandial readings will be collected and faxed in.

Visit 4:

The fourth visit we will need a final HbA1c, cholesterol, body fat, wt, and the readings for the fasting and postprandial blood glucose values from the last 30 days.  A final questionnaire will be filled out.  All the forms will be faxed to Diabetes in Control. 

Also, as for all treatments used to help control blood sugar, the potential clearly exists for excessive lowering of blood sugar. For this reason, medical supervision is required and more frequent blood glucose monitoring is essential. 

The products that will be used as part of the study are:

1.  MSM, (Arm 3 of Study) which consists of methyl sulfonyl methane, a nutritional form of biological sulfur.

MSM is a nutritional sulfur that is a naturally occurring, vital nutrient found in all living organisms and foods. It is completely sate, odorless, and non-toxic. Nutritional sulfur is an essential building block for over 150 life-sustaining substances. MSM is a powerful free radical scavenger that detoxifies the body and increases blood circulation. It also will mitigate the symptoms of any muscle onset soreness by removing the inflammation. It also assists the body in creating new and healthy cells.

2. Adaptapower 1 (Arm 2 and 3 of study)(liquid), combines four of the most researched and powerful adaptogens: eleutherococcus senticosus, schizandra chinesis, rhodiola rosea, rhaponticum carthinoides with synergistic compounds to create the ultimate ergogenic anti-stress compounds. For every day use, “these herbs,” according to Dr. Stephen Fulder, “work at the cellular level, on every cell in the body at the same time. The body is allowed full access to its energy potential and the cells remain healthy. The cells return to healthier functioning as the various body organs and systems begin to normalize. Ultimately, the entire body will normalize itself and achieve the balance that nature intended. Adaptogens are completely unique in nature. They provide benefits which are impossible to get in any other way.” These powerful herbs also assist the body in normalizing blood sugar levels.  

Adaptapower 1 is a blend of adaptogenic herbs which help the body adapt to any kind of stress. They work at the cellular level to modify our body’s reaction to stress and alter the release of harmful stress hormones such as cortisol an incredibly catabolic substance. Adaptogens also normalize the production of hormones by the body. By using adaptogenic formulas, the negative effects of stress can be greatly mitigated. 

3. EFA’s, (Arm 3 of Study) which consists of essential fats omega 3 and omega 6. Over 86% of all Americans are deficient in essential fats. These fats are essential for fat soluble vitamins assimilation, rebuilding, healthy function and detoxification of cell walls, fat metabolism, etc.

EFA is a perfect blend of 70% omega 6 and 30% omega 3 fatty acids.

4.  Adaptapower 2 (Arm 2 and 3 of study), which consists of rhaponticum carthinoides and adjuga turkistanica, is a powerful anabolic supplement. These herbs activate the body’s metabolism, stimulate the biosynthesis of protein and nucleic acids, promotes the anabolic process in the body, protect lean muscle from a catabolic effect, stimulate bone generation, etc.

 5.  Multivitamin and Mineral with Herbs (Arm 3 of study), consists of essential vitamins and minerals in very assimilable forms with special herbs such as ginkgo biloba, ginseng, roseox, boron, and cayenne.

There are both the am and pm formulas. The am formula supplies the nutrients essential for combating the elements of daily life: stress, disease, free radicals, toxins and environmental pollution. The pm formula works with the circadian rhythm in supplying the body with the replenishing nutrients that assist in the repair and maintenance that is required during the sleeping hours of the night.

6.  Logic Meal Replacement Bars (Asst. flavors)( Arm 1, 2 & 3 of study), consists of a blend of 14 grams of high quality proteins. (whey, soy, calcium casienate). All twenty two amino acids are present to help lean muscle repair, recovery and immune function. A mixture of 28 grams of  low glycemic carbohydrates that help to stabilize blood sugar levels and maximize your energy over a longer period of time. There are no high fructose corn syrups and only 3 grams of sugar thus mitigating any fat storage, blood sugar spiking or insulin response. Plus a unique blend of essential fats that are necessary for many functions of the body thus eliminating the use of cell damaging hydrogenated oils.

Logic Meal Replacement Bars are incredible in taste as well.

8.  Logic Meal  Replacement (Shake) (Arm 1, 2 & 3 of study), consists of a formulation that is the first low glycemic meal replacement shake packed with the highest quality proteins, nutritional fats, digestive enzymes, fiber, vitamins and minerals-all in a perfect 50%-25%-25% balance. Cancer fighting isoflavones and intestinal friendly FOS round out the key ingredients built into this incredible formula. These meal replacement formulas help reduce body fat levels while increasing lean muscle and strengthening the immune system. At the same time the low glycemic formula maintains blood sugar levels without any insulin response. 

Only patients who complete all 4 visits will be considered in the analysis.   Patients will be required to have a minimum of 19 fasting and 20 ppg readings each month or they  will be excluded from the analysis. The HbA₁c and the glucose levels from Visit 1 will be compared to those from Visit 4.  

If glucose and HbA₁c levels are lower with the Logic Nutrition Program^®, we will conclude that this treatment may add incremental benefit in diabetic patients. 

WORKOUT SCHEDULE (Minimum of 3 to 5 times a week)

 A 30 minute exercise routine of at least 30 minutes daily at 60% of the maximum heart rate for at least 3 to 5 days a week will be required. 

Protocol Deviations:  Limited exceptions to the protocol will be acceptable, provided that there is no marked change in the significant intent of the study.  Thus, slight modifications of numerical entry criteria and timelines are acceptable.

Starting date Janurary 20-30, 2001

If you have an interest in participating, please go to the end of this page and click on “I Agree” which will take you to the registration form to fill out.  If you have a problem with the form you can email me at diabetesincontrol@home.com  name which study, describe your type of practice and how many patients you have that might be interested in participating. 

 

Related Studies

1.  Long-term dietary treatment with increased amounts of fiber-rich low-glycemic index natural foods improves blood glucose control and reduces the number of hypoglycemic events in type 1 diabetic patients. Diabetes Care 2000 Oct;23(10):1461-6

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&

db=PubMed&list_uids=11023137&dopt=Abstract

2. Low-glycemic index foods improve long-term glycemic control in NIDDM Diabetes Care 1991 Feb;14(2):95-101

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&list_uids=2060429&dopt=Abstract

3. Improved glycemic control and lipid profile and normalized fibrinolytic activity on a low-glycemic index diet in type 2 diabetic patients.  Diabetes Care 1999 Jan;22(1):10-8

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&list_uids=10333897&dopt=Abstract

4. Beneficial effects of high dietary fiber intake in patients with type 2 diabetes mellitus.  N Engl J Med 2000 May 11;342(19):1392-8

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&list_uids=10805824&dopt=Abstract

5. Dietary advice based on the glycaemic index improves dietary profile and metabolic control in type 2 diabetic patients.  Diabet Med 1994 May;11(4):397-401

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&list_uids=8088113&dopt=Abstract

6. Utility of a short-term 25% carbohydrate diet on improving glycemic control in type 2 diabetes mellitus.  J Am Coll Nutr 1998 Dec;17(6):595-600

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&list_uids=9853539&dopt=Abstract

7.  For more information on the Glycemic Index you can go to Rick Mendosa’s site on glycemic index at : http://www.mendosa.com/gi.htm

 To enroll please click the button below.

If you agree, click here

   

 

 You must register each patient separately and if you are registering yourself, as a medical professional,  enter your name for patient and educator

 Educator Name

Title

Organization

Address

State and Zip

Email

Phone

Patient name

Type of Diabetes

Male or Female

Age

Last HbA1c, Date

Last HbA1c, Result

 

Comments:

 

For any questions, please email us at diabetesincontrol@home.com or call us at 800-798-6972