Clinical trial NCT01875354: A Prospective Study Investigating the Effects of a Novel Weight Management Program
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Utah State University
First posted: 2013-06-11
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Determine the effect of a novel weight management program on body fat mass over 90 days.
timeFrame: Days 0 and 90
Secondary outcomes:
measure: Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)
timeFrame: Throughout 1 year
measure: 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.
timeFrame: throughout 1 year
measure: Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)
timeFrame: Throughout 1 year
measure: Determine skin carotenoid (Biophotonic Scanner) measurement changes.
timeFrame: Throughout 1 year
measure: Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.
timeFrame: Days 0 and 90
measure: Evaluate the changes in inflammatory markers from the baseline visit to day 90.
timeFrame: Days 0 and 90
measure: Evaluate the changes in gene expression from the baseline visit to day 90.
timeFrame: Day 0 and 90
measure: Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365.
timeFrame: Days 0, 90, 80, and 365
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael Lefevre, PhD
role: PRINCIPAL_INVESTIGATOR
References: