A Phase 2 interventional study of IHBG-10 and Placebo in Obesity, sponsored by Avera McKennan Hospital & University Health Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-01.
Sponsored by Avera McKennan Hospital & University Health Center · Phase 2, Interventional, and Treatment
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).
A total of 30 subjects will be enrolled in this study. They will be randomized in to one of two groups. One group (of 20 subjects) will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take a placebo 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. Subjects will take the investigational product or placebo for 12 weeks. Participation in this study involves 4 study visits.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
Browse Obesity studies →Avera McKennan Hospital & University Health Center is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Subjects will take 500 mg IHBG-10 15 minutes prior to the three main meals of the day.
Dietary Supplement: IHBG-10
Subjects will take a placebo 15 minutes prior to the three main meals of the day.
Dietary Supplement: Placebo
500 mg IHBG-10
Also known as: IHBG10
Placebo taken 15 minutes prior to the three main meals of the day
Also known as: sugar pill
Weight
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
This study is withdrawn, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Avera McKennan Hospital & University Health Center