A Prospective Study Investigating the Effects of a Novel Weight Management Program



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:5/5/2014
Start Date:May 2013
Contact:Michael Lefevre, PhD
Email:chns@usu.edu
Phone:435-797-4226

Use our guide to learn which trials are right for you!

A Prospective, Randomized, Blinded, Controlled Study Investigating the Effects of a Novel Body Weight Management Program Over 90-days and Weight Maintenance at One Year.

The purpose of this study is to assess the safety and efficacy of a weight management
program composed of dietary supplements and a reduced calorie eating program.


Inclusion Criteria:

1. Male or female 18-65 years of age at the time of informed consent

2. The ability to read, speak and understand the English language in order to complete
the required paper informed consent, assessments and diary

3. Access to email and to a digital camera or camera phone

4. Willing and able to provide written informed consent

5. Willing and able to comply with the study restrictions, procedures and assessments
and attend regularly scheduled clinic visits

6. Willing and able to accommodate being contacted by the study staff for telephone call
visits, follow-up contacts, and study visit reminders

7. BMI is equal to or greater than 25 and less than or equal to 40 kg/m2

8. Use of effective method of contraception by females of childbearing potential 30-days
before the screening visit and agree to continue to practice that acceptable method
of contraception for the duration of her participation in the study

9. A resting normotensive blood pressure, as defined as a systolic blood pressure
between 150-90 mmHg and a diastolic blood pressure of between 95-50 mmHg, at
screening visit 1(A)

10. Willing to fast for at least 8 hours prior to the study procedures being performed
that require fasting measurements

11. Willing and able to follow eating program and able to consume the study supplied
Supplements, Placebos and shakes (which include whey and/or egg protein) on a daily
basis. Subjects that are lactose intolerant will be considered ineligible

12. Only one member per household eligible to participate in the study

Exclusion Criteria:

1. A subject that has any Axis I Psychiatric disorders according to the DSM-IV criteria
that would prevent the subject from being able to comply with study requirements
and/or taking anti-psychotic medication

2. Diagnosed with insomnia and is chronically using prescribed or OTC insomnia
medications

3. A self-reported chronic condition that may affect subject safety

4. An HbA1c of greater than or equal to 7.0%

5. Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less
than 50 mL/min/1.73 m2

6. Chronically using glucocorticoid steroids

7. Currently pregnant, planning to become pregnant during the course of the study or is
breastfeeding

8. Use of antihypertensive medication(s) for less than 90 days prior to screening

9. Diagnosed with any thyroid disorder or has a clinically significant out of range
laboratory value (i.e. TSH, T3 Free, and/or T4 Free) value measured at screening

10. Known allergy or intolerance to any of the ingredients contained in the Novel
Supplements, placebos or shakes (cow milk proteins)

11. Planned surgical procedure during the 365 day course of the study

12. Currently participating in another clinical research study or have done so within 30
days prior to the screening visit

13. Diagnosis of milk or egg intolerance

14. Participating in another weight loss program or using another weight loss product.
Subjects may enroll if they are willing to stop the weight loss program they are
currently on and/or washout of the product they are using. The appropriate washout
will be reviewed with the investigator or medically qualified designee on a case by
case basis

15. Fasting LDL-C greater than 190 mg/dL or triglycerides greater than 400 mg/dL.

16. Unwilling to discontinue consumption of green or black tea or green or black tea
extracts beginning at the screening visit and after signing of the informed consent

17. Unwilling to discontinue use of over-the-counter and/or prescribed vitamin
supplements except for: multivitamins, calcium, fish oil, vitamin C, vitamin D,
vitamin E, zinc or iron

18. Plans to have plastic or reconstructive surgery or any other procedure that, in the
opinion of the investigator, could influence body composition, at any time during the
year long study

19. Unable to lay supine for at least 30 minutes

20. Cognitive impairment that would limit ability to understand or follow diet
instructions and/or comply with the study protocol
We found this trial at
1
site
Logan, Utah 84322
?
mi
from
Logan, UT
Click here to add this to my saved trials