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

Avera McKennan Hospital & University Health Center10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

IHBG-10DIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Avera Research Institute

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Weight

Time frame: 12 weeks

Secondary Outcomes

Body composition

Time frame: 12 weeks

Data from ClinicalTrials.gov

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