OverweightPhase 2NCT00613600
Safety and Effectiveness Study of a Fiber Supplement for Weight Loss
A Phase 2 study testing Glucomannan and Inert microcrystalline cellulose in people with Overweight and Obesity, run by Rush University Medical Center at 1 site in United States.
Trial summary
Overweight and obesity are serious and growing problems within the United States. The usual approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in long-term weight loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Glucomannan and Inert microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > or = 18 and < or = 65 years
- body mass index (BMI) > or = 25 and < or = 35 at study entry
- speak and understand English (since translated versions of study tools have not been validated)
- for females only: without childbearing potential or negative HCG hormone blood test and use of an appropriate form of contraception
- signed informed consent form and HIPAA research authorization
Who cannot join
- current use of fiber supplements or intolerance to fiber supplements
- untreated/unstable metabolic conditions known to influence weight status (e.g., hypothyroidism, type 2 diabetes mellitus)
- gastrointestinal disorders that might cause complications or influence motility or satiety (e.g., diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
- Stage II hypertension (> or = 160/100 mg Hg) or dyslipidemia (fasting LDL cholesterol > or = 160 mg/dL; total cholesterol > or = 240 mg/dL; triglycerides > 200 mg/dL; HDL < or = 40 mg/dL)
- fasting serum glucose > 126 mg/dL
- acute or unstable cardiovascular, pulmonary, hepatic, renal, or psychiatric disorders
Show all 18Show fewer
- conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
- use of medications that might affect weight or food absorption (e.g., diuretics, glucocorticoids, anorexigenic agents, Orlistat, laxatives)
- use of CAM therapies that might affect weight (e.g., acupuncture, Hoodia)
- weight change of > 5% body weight within 3 months of entry into the study
- active eating disorders or active participation in a weight loss program
- renal function impairment as evidenced by a history of renal disease or a serum creatinine > 2.0 mg/dL
- liver function impairment as evidenced by a history of liver disease or liver enzyme elevations > three times the upper limit of normal (i.e., ALT > 150 u/L and/or AST > 165 u/L)
- evidence of depression as determined by a weighted score of > or = 16 on the Center for Epidemiological Studies Depression Scale (CES-D), as this may affect eating behavior and adherence to the study protocol
- currently consumes > or = 10 alcoholic drinks/week, as determined by self-report
- currently smokes cigarettes due to the effects of nicotine on appetite and C-reactive protein levels
- use of illicit drugs currently or in the last six months, as determined by self-report
- for females only: pregnant, less than 6 months postpartum or 6 months post-termination of pregnancy, or currently lactating, due to lack of safety data in this population
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Safety and Efficacy of Glucomannan for Weight Loss
Overweight and obesity are serious and growing problems within the United States. The usual approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a fiber supplement that has promising weight loss effects.
Read the detailed description
The primary objective of this exploratory project is to evaluate the safety and efficacy of a highly viscous, water-soluble fiber supplement, glucomannan, for achieving weight loss in overweight and moderately obese individuals. Overweight and obesity are major public health problems in the U.S. that account for substantial morbidity, mortality, and healthcare costs. Conventional approaches to weight loss are largely ineffective, particularly for long-term weight loss and maintenance. Thus, there is a critical need for safe and effective adjunctive treatments. A few, limited studies suggest that glucomannan supplementation is associated with weight loss, is well-tolerated, and has a favorable safety profile.
In this preliminary study, the target population will be overweight and moderately obese individuals, a population that accounts for nearly 50% of all U.S. adults. The specific aims of the project are to: 1) describe the safety of glucomannan for achieving weight loss in overweight and moderately obese individuals, and 2) describe the efficacy of glucomannan for achieving weight loss in overweight and moderately obese individuals. Participants will take glucomannan supplements daily for eight weeks in a double-blind, placebo-controlled, randomized clinical trial. Safety and efficacy outcome measures include: gastrointestinal symptoms/tolerance, hepatic panel, serum creatinine, weight, body composition, diet intake, hunger/fullness, lipid profile, blood glucose, and C-reactive protein. Examination of the safety and efficacy of glucomannan for achieving weight loss will extend our understanding of additional treatments that may be effective in combating a significant public health problem.
- Conditions
- Overweight, Obesity
- Being tested
- Glucomannan, Inert microcrystalline cellulose
- Keywords
- Safety, Efficacy, Glucomannan, Dietary fiber, 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
Two 665 mg capsules of glucomannan three times a day for 8 weeks
Inert microcrystalline celluloseDietary supplement
Two capsules of inert microcrystalline cellulose three times a day for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Two 665 mg capsules of glucomannan three times a day for eight weeks Receives: Dietary Supplement: Glucomannan |
| 2 | Placebo comparator | Two capsules of inert microcrystalline cellulose three times a day for eight weeks Receives: Dietary Supplement: Inert microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 8 weeks
Secondary outcomes (9)
Body composition
Measured: 8 weeks
Dietary intake
Measured: 8 weeks
Hunger and fullness
Measured: 8 weeks
Lipid profile
Measured: 8 weeks
Fasting blood glucose
Measured: 8 weeks
C-reactive protein
Measured: 8 weeks
Gastrointestinal symptoms and tolerance
Measured: 8 weeks
Hepatic panel
Measured: 8 weeks
Serum creatinine
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce K Keithley, Rush University Medical Center
- Investigators
- Joyce K Keithley, DNSc, RN, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613600
- Sponsor's protocol ID
- RTF-GM
- Status last verified
- Dec 2011
- First submitted
- 31 Jan 2008
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keithley JK, Swanson B, Mikolaitis SL, DeMeo M, Zeller JM, Fogg L, Adamji J. Safety and efficacy of glucomannan for weight loss in overweight and moderately obese adults. J Obes. 2013;2013:610908. doi: 10.1155/2013/610908. Epub 2013 Dec 30.
PubMed 24490058
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Glucomannan for Weight Loss
- ClinicalTrials.gov ID
- NCT00613600
- Acronym / sponsor ID
- RTF-GM
- Conditions
- Overweight, Obesity
- Keywords
- Safety, Efficacy, Glucomannan, Dietary fiber, Weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Feb 2008 (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.
Overweight and obesity are serious and growing problems within the United States. The usual approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a fiber supplement that has promising weight loss effects.
Detailed description
The primary objective of this exploratory project is to evaluate the safety and efficacy of a highly viscous, water-soluble fiber supplement, glucomannan, for achieving weight loss in overweight and moderately obese individuals. Overweight and obesity are major public health problems in the U.S. that account for substantial morbidity, mortality, and healthcare costs. Conventional approaches to weight loss are largely ineffective, particularly for long-term weight loss and maintenance. Thus, there is a critical need for safe and effective adjunctive treatments. A few, limited studies suggest that glucomannan supplementation is associated with weight loss, is well-tolerated, and has a favorable safety profile.
In this preliminary study, the target population will be overweight and moderately obese individuals, a population that accounts for nearly 50% of all U.S. adults. The specific aims of the project are to: 1) describe the safety of glucomannan for achieving weight loss in overweight and moderately obese individuals, and 2) describe the efficacy of glucomannan for achieving weight loss in overweight and moderately obese individuals. Participants will take glucomannan supplements daily for eight weeks in a double-blind, placebo-controlled, randomized clinical trial. Safety and efficacy outcome measures include: gastrointestinal symptoms/tolerance, hepatic panel, serum creatinine, weight, body composition, diet intake, hunger/fullness, lipid profile, blood glucose, and C-reactive protein. Examination of the safety and efficacy of glucomannan for achieving weight loss will extend our understanding of additional treatments that may be effective in combating a significant public health problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: GlucomannanTwo 665 mg capsules of glucomannan three times a day for eight weeks |
| 2 | Placebo comparator | Dietary Supplement: Inert microcrystalline celluloseTwo capsules of inert microcrystalline cellulose three times a day for eight weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > or = 18 and < or = 65 years
- body mass index (BMI) > or = 25 and < or = 35 at study entry
- speak and understand English (since translated versions of study tools have not been validated)
- for females only: without childbearing potential or negative HCG hormone blood test and use of an appropriate form of contraception
- signed informed consent form and HIPAA research authorization
Key exclusion criteria (18 listed)
- current use of fiber supplements or intolerance to fiber supplements
- untreated/unstable metabolic conditions known to influence weight status (e.g., hypothyroidism, type 2 diabetes mellitus)
- gastrointestinal disorders that might cause complications or influence motility or satiety (e.g., diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
- Stage II hypertension (> or = 160/100 mg Hg) or dyslipidemia (fasting LDL cholesterol > or = 160 mg/dL; total cholesterol > or = 240 mg/dL; triglycerides > 200 mg/dL; HDL < or = 40 mg/dL)
- fasting serum glucose > 126 mg/dL
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 |
|---|---|---|
| GlucomannanTwo 665 mg capsules of glucomannan three times a day for 8 weeks | Dietary supplement | 1 |
| Inert microcrystalline celluloseTwo capsules of inert microcrystalline cellulose three times a day for eight weeks | Dietary supplement | 2 |
Primary outcome
Weight loss
Time frame: 8 weeks
9 secondary outcomes
Body composition
Time frame: 8 weeks
Dietary intake
Time frame: 8 weeks
Hunger and fullness
Time frame: 8 weeks
Lipid profile
Time frame: 8 weeks
Fasting blood glucose
Time frame: 8 weeks
C-reactive protein
Time frame: 8 weeks
Gastrointestinal symptoms and tolerance
Time frame: 8 weeks
Hepatic panel
Time frame: 8 weeks
Serum creatinine
Time frame: 8 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 2 Dec 2011.
- Derived from this study: PubMed 24490058Keithley JK, Swanson B, Mikolaitis SL, DeMeo M, Zeller JM, Fogg L, Adamji J. Safety and efficacy of glucomannan for weight loss in overweight and moderately obese adults. J Obes. 2013;2013:610908. doi: 10.1155/2013/610908. Epub 2013 Dec 30.
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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.
Joyce K Keithley, DNSc, RN principal investigator
Rush University Medical 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 Glucomannan and Inert microcrystalline cellulose in people with Overweight and Obesity, run by Rush University Medical 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 5 inclusion and 18 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 2 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 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 loss (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00613600, which also lists 1 linked publication.
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 2 Dec 2011.