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Effects of a Nutritional Supplement Combination on Body Weight Management

Primary Purpose

Safety/Effacy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Nutritional supplement and protein shakes

About this trial

This is an interventional treatment trial for Safety/Effacy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Females and Males aged 25-65 years
Signed informed consent
BMI between 25 and 40 kg/m2
A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal
Ability to speak and understand English
Willing to fast the morning of visit where blood samples are taken

Exclusion Criteria:

Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure.
Having undergone gastroplasty or bariatric surgery in the past 10 years.
Taking medication (e.g., thyroid medication), must be stable for at least four months.
Allergies to any ingredients contained in the Nutritional Supplement.
Medical treatment for insomnia or depression within 30-days prior to the screening visit.
Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
Planned surgical procedure during the course of the study.
Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day 0.
Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.

Sites / Locations

Aspen Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Supplement

Arm Description

Treatment Regimen -The Nutritional Supplement will be given for approximately 90 days in the form of 7 capsules and a powder to mix into liquids or foods for the first 15 days of program. Subjects will also drink a protein shake.

Outcomes

Primary Outcome Measures

-Evaluate the changes in body composition as determined by percent body fat using the Bod Pod

Secondary Outcome Measures

Evaluate the changes in body weight

Determine the safety and tolerability of a weight loss system and dietary supplements containing ingredients to promote healthy weight Evaluate the changes in body weight as measured by body weight and body composition changes (as determined by BMI as well as changes in body measurements-waist, hip, arm, and ankle circumferences) of a weight loss system and dietary supplements containing ingredients to promote healthy weight. Determine changes in substrate energy utilization Determine subjective measurements of hunger, appetite, feeling of well being during weight loss Determine changes in expansion and return of blood vessels (pulse wave analyzer)

Full Information

NCT ID

NCT01725958

First Posted

October 19, 2012

Last Updated

October 27, 2014

Sponsor

Pharmanex

Collaborators

Nu Skin Enterprises

1. Study Identification

Unique Protocol Identification Number

NCT01725958

Brief Title

Effects of a Nutritional Supplement Combination on Body Weight Management

Official Title

A Phase IV, Open-label, Parallel Group, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management Over a 90-day Period

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmanex

Collaborators

Nu Skin Enterprises

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period

Detailed Description

Safety assessment: Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the nutritional supplement. Efficacy Assessment: The objectives of this study are to evaluate the efficacy (changes in body composition and measurements as well as influence on appetite and quality of life changes) of the nutritional supplement administered repeatedly throughout the study. Study Subject Population: Healthy adult men and women are eligible for participation upon fulfillment of the inclusion/exclusion criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety/Effacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary Supplement

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional supplement and protein shakes

Primary Outcome Measure Information:

Title

-Evaluate the changes in body composition as determined by percent body fat using the Bod Pod

Time Frame

90 Days

Secondary Outcome Measure Information:

Title

Evaluate the changes in body weight

Description

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females and Males aged 25-65 years Signed informed consent BMI between 25 and 40 kg/m2 A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal Ability to speak and understand English Willing to fast the morning of visit where blood samples are taken Exclusion Criteria: Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue) Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study. Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure. Having undergone gastroplasty or bariatric surgery in the past 10 years. Taking medication (e.g., thyroid medication), must be stable for at least four months. Allergies to any ingredients contained in the Nutritional Supplement. Medical treatment for insomnia or depression within 30-days prior to the screening visit. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit. Planned surgical procedure during the course of the study. Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study. Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day 0. Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Poole, BS

Organizational Affiliation

Pharmanex

Official's Role

Study Director

Facility Information:

Facility Name

Aspen Clinical Research

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

12. IPD Sharing Statement

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Effects of a Nutritional Supplement Combination on Body Weight Management

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