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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Utah State University
Information provided by (Responsible Party):
Pharmanex
ClinicalTrials.gov Identifier:
NCT01875354
First received: June 5, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Subjects Between 18-25 Years of Age With BMI >/= 25 and </= 40 kg/m².
Dietary Supplement: Dietary Supplements and TR90 Eating Plan
Dietary Supplement: Placebo and Low Fat Eating Plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pharmanex:

Primary Outcome Measures:
  • Determine the effect of a novel weight management program on body fat mass over 90 days. [ Time Frame: Days 0 and 90 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events) [ Time Frame: Throughout 1 year ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: throughout 1 year ] [ Designated as safety issue: No ]
  • Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing) [ Time Frame: Throughout 1 year ] [ Designated as safety issue: No ]
  • Determine skin carotenoid (Biophotonic Scanner) measurement changes. [ Time Frame: Throughout 1 year ] [ Designated as safety issue: No ]
    Biophotonic Scanner utilizes raman spectroscopy to determine skin carotenoid concentrations.

  • Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90. [ Time Frame: Days 0 and 90 ] [ Designated as safety issue: No ]
    Leptin, Insulin, Adiponectin, Pancreatic Polypeptide, gLP1, C-peptide, Glucagon, Resistin and HbA1c

  • Evaluate the changes in inflammatory markers from the baseline visit to day 90. [ Time Frame: Days 0 and 90 ] [ Designated as safety issue: No ]
    hsCRP, IL-6 and TNF Receptors 60 and 80

  • Evaluate the changes in gene expression from the baseline visit to day 90. [ Time Frame: Day 0 and 90 ] [ Designated as safety issue: No ]
    Full gene arrays will be made on peripheral blood mononuclear cells. The gene expression changes will be made at baseline and day 90. There will also be a comparison back to proteins (i.e. hormones and inflammatory markers).

  • Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365. [ Time Frame: Days 0, 90, 80, and 365 ] [ Designated as safety issue: No ]
    Resting metabolic rate (RMR)and substrate utilization (R-values to determine wheather subjects are utilizing more fats or carbohydrates to meet energy demands) will be measured by CPET Quark.


Estimated Enrollment: 140
Study Start Date: May 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo and Low Fat Eating Plan

Placebo Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Placebo Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Placebo Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal)

The placebo group will be instructed to consume every day, a low fat standard of care eating plan delivering approximately 1200-1500 Kcals.

Dietary Supplement: Placebo and Low Fat Eating Plan
Experimental: Dietary Supplements and TR90 Eating Plan

Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal)

Experimental group will be instructed to consume every day, dietary supplements and a moderate protein eating plan delivering approximately 1200-1500 Kcals.

Dietary Supplement: Dietary Supplements and TR90 Eating Plan
Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875354

Locations
United States, Utah
Utah State University
Logan, Utah, United States, 84322
Sponsors and Collaborators
Pharmanex
Utah State University
Investigators
Principal Investigator: Michael Lefevre, PhD Utah State University
  More Information

No publications provided

Responsible Party: Pharmanex
ClinicalTrials.gov Identifier: NCT01875354     History of Changes
Other Study ID Numbers: 13-PHX-01-NU-02
Study First Received: June 5, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014