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

Avera McKennan Hospital & University Health Center

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: IHBG-10; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01272739

ARI-1300-IHBG10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.

Treatment:

Dietary Supplement: IHBG-10

Control Group

Placebo Comparator group

Description:

Subjects will take a placebo 15 minutes prior to the three main meals of the day.

Treatment:

Dietary Supplement: Placebo