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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucomannan | Active Comparator | Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day. |
|
| Placebo | Placebo Comparator | Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucomannan | Dietary Supplement | Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | The primary outcome is the difference between weight at 12 weeks and the baseline weight. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects | Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function. | Assessed at 2, 4, 8, and 12 week intervals |
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Inclusion Criteria:
Exclusion Criteria:
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
Currently on one of the following medications known to cause weight loss:
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
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| Name | Affiliation | Role |
|---|---|---|
| Steve Smith, MS, RPh | The Toledo Hospital | Study Director |
| Ashley M Parrott, PharmD | The Toledo Hospital | Study Chair |
| Louito Edje, MD | The Toledo Hospital | Study Chair |
| Lindsey Bostelman, MD | The Toledo Hospital | Study Chair |
| David Knieriem | The Toledo Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W.W. Knight Family Practice Center | Toledo | Ohio | 43606 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2013 | |
| Reset | Jul 5, 2013 | |
| Release | Nov 13, 2013 | |
| Reset | Jan 2, 2014 | |
| Release | Mar 30, 2016 | |
| Reset | May 2, 2016 | |
| Release | Sep 28, 2016 | |
| Reset | Nov 18, 2016 | |
| Release | Mar 6, 2020 | |
| Reset | Mar 19, 2020 | |
| Release | Nov 23, 2021 | |
| Reset | Jan 26, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2013 | Jul 5, 2013 | |||
| Nov 13, 2013 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C022901 | (1-6)-alpha-glucomannan |
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| Placebo | Dietary Supplement | Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day. |
|
| Jan 2, 2014 |
| Mar 30, 2016 | May 2, 2016 |
| Sep 28, 2016 | Nov 18, 2016 |
| Mar 6, 2020 | Mar 19, 2020 |
| Nov 23, 2021 | Jan 26, 2022 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |