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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272739
• Other study ID #: ARI-1300-IHBG10
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2011
• Last updated: October 4, 2011
• Start date: February 2011
• Est. completion date: July 2011

Study information

• Verified date: January 2011
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• IHBG-10
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
• Placebo
Placebo taken 15 minutes prior to the three main meals of the day

Locations

Country	Name	City	State
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		12 weeks	No
Secondary	Body composition		12 weeks	No