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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01272739
First received: January 6, 2011
Last updated: October 4, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Dietary Supplement: IHBG-10
Dietary Supplement: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • placebo
  • sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272739

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Edward Zawada, MD Avera McKennan Hospital & University Health Center
  More Information

No publications provided

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01272739     History of Changes
Other Study ID Numbers: ARI-1300-IHBG10
Study First Received: January 6, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
obesity
weight loss
weight management
overweight
nutriceutical

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013