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

October 4, 2011 updated by: Avera McKennan Hospital & University Health Center

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.
Dietary supplement: IHBG-10
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
Other Names:
  • IHBG10
Placebo Comparator: Control Group
Subjects will take a placebo 15 minutes prior to the three main meals of the day.
Dietary supplement: Placebo
Placebo taken 15 minutes prior to the three main meals of the day
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Investigators

  • Principal Investigator: Edward Zawada, MD, Avera McKennan Hospital & University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI-1300-IHBG10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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