OverweightPhase 4NCT01485718
Effect of Daily Glucomannan in Overweight Patients
A Phase 4 study testing Glucomannan in people with Overweight and Obesity, run by ProMedica Health System at 1 site in United States.
Trial summary
Glucomannan is a dietary supplement that has been marketed for weight loss. There is some research that supports this claim but more research is necessary. This is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Glucomannan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2012
- Phase
- Phase 4
- 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
- Patients ≥18 years old
- Overweight (BMI ≥ 25 kg/m2)
Who cannot join
- Pregnant or nursing women
- Women of childbearing age will be excluded unless they are on some form of contraception
- Participation in any other formal or informal weight reduction program
- Currently enrolled in another weight loss study
- Currently enrolled in a weight loss program
- Active attempt to lose weight with diet and/or exercise within the last month
Show all 23Show fewer
- Currently on one of the following medications known to cause weight loss:
- Alli/Xenical(orlistat)
- Adipex-P (phentermine)
- Bontril (phendimetrazine)
- Dexoxyn (methamphetamine)
- Didrex (benzphetamine)
- Tenuate (diethylpropion)
- Meridia (sibutramine)
- Byetta (exenatide) or Victoza (liraglutide)
- Stimulants
- Recently (within the last three months) started on any medication that may cause weight gain
- A diagnosis of heart failure
- Structural abnormalities of the esophagus or gut
- Previous GI surgery for weight reduction
- Inflammatory bowel or irritable bowel disease
- A life expectancy of <6 months
- Allergy to glucomannan or any component of the placebo
Trial locations and contacts
1 site in 1 country.
United States1 site
W.W. Knight Family Practice Center
Toledo, Ohio, 43606
About this study
Glucomannan is a dietary supplement that has been marketed for weight loss. There is some research that supports this claim but more research is necessary. This is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age who are overweight.
Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times daily. The study will last for 12 weeks.
At the start of the study participants will be asked questions about current medications and diet/exercise regimen, a weight and height will be obtained, and they will be given a one-month's supply of study supplement. An investigator will call each participant after they have been taking the supplement for 2 weeks to ensure that the participant is tolerating the supplement and answer any questions. Throughout the study, participants will be required to follow-up with investigators in the office every 4 weeks (a total of 3 follow-up appointments). Every 4 weeks, the investigators will weigh participants, count the leftover capsules from the previous month, and ask about any adverse effects you may be experiencing. At the conclusion of the study, a final weight will be compared with the baseline weight to determine if the medication had an effect on weight loss.
- Conditions
- Overweight, Obesity
- Being tested
- Glucomannan, Placebo
- Keywords
- Obesity, Overweight, Weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucomannanDietary supplement
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks
PlaceboDietary supplement
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
| Study group | Role | What they receive |
|---|---|---|
| Glucomannan | Active comparator | Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day. Receives: Dietary Supplement: Glucomannan |
| Placebo | Placebo comparator | Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest 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
The primary outcome is the difference between weight at 12 weeks and the baseline weight.
Measured: 12 weeks
Secondary outcomes (1)
Side Effects
Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function.
Measured: Assessed at 2, 4, 8, and 12 week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Cochran, ProMedica Health System
- Investigators
- Steve Smith, MS, RPh, Study director, The Toledo HospitalAshley M Parrott, PharmD, Study chair, The Toledo HospitalLouito Edje, MD, Study chair, The Toledo HospitalLindsey Bostelman, MD, Study chair, The Toledo HospitalDavid Knieriem, Study chair, The Toledo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485718
- Sponsor's protocol ID
- 11-117
- Status last verified
- Dec 2011
- First submitted
- 26 Nov 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Glucomannan in Overweight Patients
- ClinicalTrials.gov ID
- NCT01485718
- Acronym / sponsor ID
- 11-117
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, Overweight, Weight loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 5 Dec 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.
Glucomannan is a dietary supplement that has been marketed for weight loss. There is some research that supports this claim but more research is necessary. This is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age who are overweight.
Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times daily. The study will last for 12 weeks.
At the start of the study participants will be asked questions about current medications and diet/exercise regimen, a weight and height will be obtained, and they will be given a one-month's supply of study supplement. An investigator will call each participant after they have been taking the supplement for 2 weeks to ensure that the participant is tolerating the supplement and answer any questions. Throughout the study, participants will be required to follow-up with investigators in the office every 4 weeks (a total of 3 follow-up appointments). Every 4 weeks, the investigators will weigh participants, count the leftover capsules from the previous month, and ask about any adverse effects you may be experiencing. At the conclusion of the study, a final weight will be compared with the baseline weight to determine if the medication had an effect on weight loss.
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 |
|---|---|---|
| Glucomannan | Active comparator | Dietary Supplement: GlucomannanParticipants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest 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 (2 listed)
- Patients ≥18 years old
- Overweight (BMI ≥ 25 kg/m2)
Key exclusion criteria (23 listed)
- Pregnant or nursing women
- Women of childbearing age will be excluded unless they are on some form of contraception
- Participation in any other formal or informal weight reduction program
- Recently (within the last three months) started on any medication that may cause weight gain
- A diagnosis of heart failure
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 |
|---|---|---|
| GlucomannanParticipants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks | Dietary supplement | Glucomannan |
| PlaceboParticipants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day. | Dietary supplement | Placebo |
Primary outcome
Weight
Time frame: 12 weeks
The primary outcome is the difference between weight at 12 weeks and the baseline weight.
1 secondary outcome
Side Effects
Time frame: Assessed at 2, 4, 8, and 12 week intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Steve Smith, MS, RPh study director
The Toledo Hospital
Ashley M Parrott, PharmD study chair
The Toledo Hospital
Louito Edje, MD study chair
The Toledo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucomannan in people with Overweight and Obesity, run by ProMedica Health System 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 2 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 13 Dec 2011.