Randomized Study to Evaluate the Effect of an Investigati... | NCT01272739

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

NCT01272739

Sponsor

Avera McKennan Hospital & University Health Center

Status

Completed

Last Update Posted

Oct 6, 2011Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Obesity

Interventions

IHBG-10
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 6, 2011

First Posted Date

Jan 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2011

Last Update Posted Date

Oct 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.	Dietary Supplement: IHBG-10
Control Group	Placebo Comparator	Subjects will take a placebo 15 minutes prior to the three main meals of the day.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IHBG-10	Dietary Supplement	500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day	Study Group

Measure	Description	Time Frame
Weight		12 weeks

Measure	Description	Time Frame
Body composition		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward Zawada, MD	Avera McKennan Hospital & University Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avera Research Institute		Sioux Falls	South Dakota	57105	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided