ObesityPhase 2NCT01272739
Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition
A Phase 2 study testing IHBG-10 in people with Obesity, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- IHBG-10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- IHBG-10, Placebo
- Keywords
- obesity, weight loss, weight management, overweight, nutriceutical
- Medical subject headings
- Obesity, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHBG-10Dietary supplement
Also called IHBG10
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
PlaceboDietary supplement
Also called sugar pill
Placebo taken 15 minutes prior to the three main meals of the day
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day. Receives: Dietary Supplement: IHBG-10 |
| Control Group | Placebo comparator | Subjects will take a placebo 15 minutes prior to the three main meals of the day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 12 weeks
Secondary outcomes (1)
Body composition
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Zawada, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272739
- Sponsor's protocol ID
- ARI-1300-IHBG10
- Status last verified
- Jan 2011
- First submitted
- 6 Jan 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition
- ClinicalTrials.gov ID
- NCT01272739
- Acronym / sponsor ID
- ARI-1300-IHBG10
- Conditions
- Obesity
- Keywords
- obesity, weight loss, weight management, overweight, nutriceutical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Dietary Supplement: IHBG-10Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboSubjects will take a placebo 15 minutes prior to the three main meals of the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IHBG-10Also: IHBG10500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day | Dietary supplement | Study Group |
| PlaceboAlso: sugar pillPlacebo taken 15 minutes prior to the three main meals of the day | Dietary supplement | Control Group |
Primary outcome
Weight
Time frame: 12 weeks
1 secondary outcome
Body composition
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Zawada, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IHBG-10 in people with Obesity, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.