Status:
COMPLETED
A Prospective Study Investigating the Effects of a Novel Weight Management Program
Lead Sponsor:
Pharmanex
Collaborating Sponsors:
Utah State University
Conditions:
Overweight
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- Male or female 18-65 years of age at the time of informed consent
- The ability to read, speak and understand the English language in order to complete the required paper informed consent, assessments and diary
- Access to email and to a digital camera or camera phone
- Willing and able to provide written informed consent
- Willing and able to comply with the study restrictions, procedures and assessments and attend regularly scheduled clinic visits
- Willing and able to accommodate being contacted by the study staff for telephone call visits, follow-up contacts, and study visit reminders
- BMI is equal to or greater than 25 and less than or equal to 40 kg/m2
- 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
- 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)
- Willing to fast for at least 8 hours prior to the study procedures being performed that require fasting measurements
- 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
- Only one member per household eligible to participate in the study
Exclusion
- 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
- Diagnosed with insomnia and is chronically using prescribed or OTC insomnia medications
- A self-reported chronic condition that may affect subject safety
- An HbA1c of greater than or equal to 7.0%
- Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less than 50 mL/min/1.73 m2
- Chronically using glucocorticoid steroids
- Currently pregnant, planning to become pregnant during the course of the study or is breastfeeding
- Use of antihypertensive medication(s) for less than 90 days prior to screening
- 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
- Known allergy or intolerance to any of the ingredients contained in the Novel Supplements, placebos or shakes (cow milk proteins)
- Planned surgical procedure during the 365 day course of the study
- Currently participating in another clinical research study or have done so within 30 days prior to the screening visit
- Diagnosis of milk or egg intolerance
- 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
- Fasting LDL-C greater than 190 mg/dL or triglycerides greater than 400 mg/dL.
- 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
- 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
- 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
- Unable to lay supine for at least 30 minutes
- Cognitive impairment that would limit ability to understand or follow diet instructions and/or comply with the study protocol
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01875354
Start Date
May 1 2013
End Date
November 1 2014
Last Update
April 5 2017
Active Locations (1)
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1
Utah State University
Logan, Utah, United States, 84322