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

NCT ID: NCT01875354

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo and Low Fat Eating Plan

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: EXPERIMENTAL

Dietary Supplements and TR90 Eating Plan

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo and Low Fat Eating Plan

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Utah State University

OTHER

Sponsor Role: collaborator

Pharmanex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lefevre, PhD

Role: PRINCIPAL_INVESTIGATOR

Utah State University

Locations

Utah State University

Logan, Utah, United States

Countries

United States

Other Identifiers

13-PHX-01-NU-02

Identifier Type: -

Identifier Source: org_study_id