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Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IHBG-10
Placebo
Sponsored by
Avera McKennan Hospital & University Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, weight management, overweight, nutriceutical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 and older
  • Body mass index of 30 or greater
  • Agree to keep diet, exercise and all current health habits stable during participation in the study

Exclusion Criteria:

  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Prior bariatric surgery
  • Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
  • Obesity as a result of a clinically diagnosed endocrine problem
  • Currently taking an anti-psychotic medication
  • History of peptic ulcer disease

Sites / Locations

  • Avera Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group

Control Group

Arm Description

Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.

Subjects will take a placebo 15 minutes prior to the three main meals of the day.

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Body composition

Full Information

First Posted
January 6, 2011
Last Updated
October 4, 2011
Sponsor
Avera McKennan Hospital & University Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01272739
Brief Title
Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avera McKennan Hospital & University Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.
Detailed Description
Subjects will be randomized to one of two groups: one group will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; the other group will take placebo 15 minutes prior to the three main meals of the day. Subjects will be on the investigational product or placebo for 12 weeks. Participation in this study involves four study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight loss, weight management, overweight, nutriceutical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Subjects will take a placebo 15 minutes prior to the three main meals of the day.
Intervention Type
Dietary Supplement
Intervention Name(s)
IHBG-10
Other Intervention Name(s)
IHBG10
Intervention Description
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo taken 15 minutes prior to the three main meals of the day
Primary Outcome Measure Information:
Title
Weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 and older Body mass index of 30 or greater Agree to keep diet, exercise and all current health habits stable during participation in the study Exclusion Criteria: Women who are pregnant, breastfeeding or planning to become pregnant Prior bariatric surgery Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month Obesity as a result of a clinically diagnosed endocrine problem Currently taking an anti-psychotic medication History of peptic ulcer disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Zawada, MD
Organizational Affiliation
Avera McKennan Hospital & University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

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Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition

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