Metabolic Syndrome XNCT00129792
Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
A study testing Dietary supplement for weight loss and Education and counseling for weight loss in people with Metabolic Syndrome X and Prediabetic State, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will determine the effects of a supplement in reducing symptoms of metabolic syndrome, a collection of symptoms that increase the risk for developing heart disease, stroke, and diabetes. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Metabolic Syndrome X, Prediabetic State, Insulin Resistance
- What is being tested?
- Dietary supplement for weight loss and Education and counseling for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2014
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) between 30 and 45
- Live in the Portland, Oregon metropolitan area
- Willing and able to complete a 12-week weight loss program
- Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher
Who cannot join
- Any medications, including dietary supplements, that could interfere with the study
- Medical conditions contraindicating a diet and exercise weight loss program
- History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
- Current diagnosis of cancer
- Hospitalization for a psychiatric condition within 12 months prior to study entry
- Weight loss medications within 6 months prior to study entry
Show all 15Show fewer
- Change in body weight greater than 5% within 6 months prior to study entry
- Consumption of more than 21 alcoholic drinks per week
- Current participation in another clinical trial OR living in the same household with another participant in this study
- Currently exercising for more than 30 minutes, 3 times per week
- Fasting blood glucose higher than 125 mg/dl
- BP higher than 145/90
- Triglycerides higher than 500 mg/dl
- Training as a health care provider or health scientist
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University General Clinical Research Center
Portland, Oregon, 97239
About this study
Official title: Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
This study will determine the effects of a supplement in reducing symptoms of metabolic syndrome, a collection of symptoms that increase the risk for developing heart disease, stroke, and diabetes.
Read the detailed description
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants' thoughts about their ability to make behavioral changes.
- Being tested
- Dietary supplement for weight loss, Education and counseling for weight loss
- Keywords
- Blood Glucose, Cholesterol, Weight Loss, Insulin, Complementary Therapies
- Medical subject headings
- Metabolic Syndrome, Prediabetic State, Insulin Resistance, Obesity, Metabolic Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement for weight lossDrug
The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
Education and counseling for weight lossBehavioural
Hour and a half weight loss education session weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Has 100% expectation of receiving supplement Receives: Drug: Dietary supplement for weight loss; Behavioral: Education and counseling for weight loss |
| 2 | Sham comparator | Has 50% expectation of receiving supplement Receives: Drug: Dietary supplement for weight loss; Behavioral: Education and counseling for weight loss |
| 3 | Other | Has 0% expectation of receiving supplement. Receives: Behavioral: Education and counseling for weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol
Measured: baseline (Week 1) and outcome (Week 12)
insulin function
Measured: baseline (Week 1) and outcome (Week 12)
weight loss
Measured: baseline (Week 1) and outcome (Week 12)
Secondary outcomes (1)
Cortisol levels
Measured: baseline (Week 1) and outcome (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry Oken, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129792
- Sponsor's protocol ID
- U19AT002656
- Other IDs
- U19AT002656-03, U19AT002656-02, U19AT002656
- Status last verified
- Oct 2014
- First submitted
- 10 Aug 2005
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00129792
- Acronym / sponsor ID
- U19AT002656
- Keywords
- Blood Glucose, Cholesterol, Weight Loss, Insulin, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Aug 2005 (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 study will determine the effects of a supplement in reducing symptoms of metabolic syndrome, a collection of symptoms that increase the risk for developing heart disease, stroke, and diabetes.
Detailed description
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants' thoughts about their ability to make behavioral changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dietary supplement for weight loss, Behavioral: Education and counseling for weight lossHas 100% expectation of receiving supplement |
| 2 | Sham comparator | Drug: Dietary supplement for weight loss, Behavioral: Education and counseling for weight lossHas 50% expectation of receiving supplement |
| 3 | Other | Behavioral: Education and counseling for weight lossHas 0% expectation of receiving supplement. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 30 and 45
- Live in the Portland, Oregon metropolitan area
- Willing and able to complete a 12-week weight loss program
- Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher
Key exclusion criteria (15 listed)
- Any medications, including dietary supplements, that could interfere with the study
- Medical conditions contraindicating a diet and exercise weight loss program
- History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
- Current diagnosis of cancer
- Hospitalization for a psychiatric condition within 12 months prior to study entry
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 |
|---|---|---|
| Dietary supplement for weight lossThe dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function. | Drug | 1, 2 |
| Education and counseling for weight lossHour and a half weight loss education session weekly for 12 weeks. | Behavioural | 1, 2, 3 |
Primary outcome
Cholesterol
Time frame: baseline (Week 1) and outcome (Week 12)
insulin function
Time frame: baseline (Week 1) and outcome (Week 12)
weight loss
Time frame: baseline (Week 1) and outcome (Week 12)
1 secondary outcome
Cortisol levels
Time frame: baseline (Week 1) and outcome (Week 12)
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 29 Oct 2014.
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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.
Barry Oken, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement for weight loss and Education and counseling for weight loss in people with Metabolic Syndrome X and Prediabetic State, run by Oregon Health and Science University 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 4 inclusion and 15 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 29 Oct 2014. 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.
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?
Cholesterol (time frame: baseline (Week 1) and outcome (Week 12)). The study lists 3 primary outcomes in all. 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 29 Oct 2014.