Novel Nutritional Blend Study

A dietary supplement study to determine the effects of a blend of nutritional ingredients on

metabolic parameters, inflammatory factors and safety

Introduction

• This 4-month study was designed to test the effects of a dietary blend of supplement ingredients on multiple health factors including blood sugar, triglycerides and whole body inflammation.

• The supplements will be taken in the form of 4 pills per day with 2 pills consumed with breakfast and 2 pills with dinner.

• This is an open label study meaning that the participant and researchers will know what he/she is taking.

Introduction

This is a study targeted at individuals…

• between 30-70 years of age

• living in the Cache County, Utah area

• who have no difficulty with swallowing pills

• willing to fast for at least 8 hours & have blood drawn on 4 different occasions

• willing to maintain their regular diet and level of activity

• willing to discontinue their dietary supplements during the study

Recruiting Inclusions

You may qualify if you have several of the following conditions:

• Body mass index (BMI) of > 27 (there are multiple websites for

calculating your BMI)

• Elevated blood sugar

• Increased waist size

• Low HDL (good) cholesterol

• High triglycerides

Recruiting Exclusions

You will not qualify if you…

• Are taking diabetic medication(s)

• Currently use nicotine or have discontinued nicotine use in the last 12 months

• Have had certain surgeries on your intestines that may interfere with absorption of nutrients

• Are pregnant, trying to become pregnant, or you are breastfeeding

• Take prescribed medicine to thin your blood (anticoagulants)

• Take medicine that lowers your immune system

Other requirements for participation

• You will be asked to discontinue taking all of your dietary supplements for the study. An optional multivitamin will be provided.

Other requirements for participation

• Known allergies to any of the supplement ingredients will disqualify you from participating. We will provide you with a list of the ingredients.

Other requirements for participation

• Certain laboratory findings obtained during the screening visit may disqualify you from participating. You will be notified if this happens.

Benefits to you if you qualify

Medical Tests• Free medical tests

including blood work and an electrocardiogram (ECG) of your heart

• There is no cost to you to participate in this study

What to expect

• In addition to having your blood drawn and an ECG, clinic visits will include measurements of your height, weight, blood pressure and temperature. We will also utilize the BioPhotonic Scanner, a tool used to estimate your antioxidant status related to your dietary intake of fruits and vegetables.

What to Expect

Following the initial clinic screening visit, the Investigator will review your results and determine if you qualify for this study. If you qualify, the following will happen during this 4-month study:

• 3 more clinic visits (~ 1 ½ hours each)

• 4 telephone visits (~ 5 minutes each)

• All visits will include questions about changes in your health status and whether you are taking the supplements as instructed. A minimum of 80% compliance with supplement intake is required to remain in the study

What to Expect

If you qualify and decide to participate, you can earn up to $500 for your participation. This is to compensate you for your time and inconvenience.

How do I sign up?

• To see if you qualify, complete the survey by copying this link into your browser: https://usu.co1.qualtrics.com/SE/?SID=SV_5BVhjoeWU1ImWqN

• You will be contacted by a study staff member to schedule a screening visit

If you have questions that have not been answered, email or call the study coordinator, Janet Bergeson, RN

janet.bergeson@usu.edu

Office phone: 435-797-8262