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.

Pharmanex1 site in 1 country141 target enrollmentMay 2013

ConditionsOverweight

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight
Sponsor: Pharmanex
Enrollment: 141
Locations: 1
Primary Endpoint: Determine the effect of a novel weight management program on body fat mass over 90 days.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

November 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pharmanex

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)

Outcomes

Primary Outcomes

Determine the effect of a novel weight management program on body fat mass over 90 days.

Time Frame: Days 0 and 90

Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.

Secondary Outcomes

Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)(Throughout 1 year)
Evaluate the changes in gene expression from the baseline visit to day 90.(Day 0 and 90)
Determine skin carotenoid (Biophotonic Scanner) measurement changes.(Throughout 1 year)
Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365.(Days 0, 90, 80, and 365)
Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)(Throughout 1 year)
Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.(Days 0 and 90)
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.(throughout 1 year)
Evaluate the changes in inflammatory markers from the baseline visit to day 90.(Days 0 and 90)