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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272739

Enrollment

Registered

2011-01-10

Start date

2011-02-28

Completion date

2011-07-31

Last updated

2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, weight loss, weight management, overweight, nutriceutical

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.

Interventions

DIETARY_SUPPLEMENTIHBG-10

500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day

DIETARY_SUPPLEMENTPlacebo

Placebo taken 15 minutes prior to the three main meals of the day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Weight	12 weeks

Secondary

Measure	Time frame
Body composition	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026