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NCT Number: NCT01272739

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IHBG-10

Dietary Supplement

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

Other names: IHBG10

Placebo

Dietary Supplement

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

Other names: sugar pill

Primary outcomes

  1. Weight

    Time frame: 12 weeks

Secondary outcomes

  1. Body composition

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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