OverweightNCT00502658
Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
A study testing Dietary supplement containing vitamins, minerals, and herbs, Shakes with nutrients and herbs and Personal energy tracking tool in people with Overweight and Obesity, run by Pharmanex at 1 site in United States.
Trial summary
Excessive body weight is becoming a concern around the world, for example over half of the American adult population is overweight or obese. The purpose of this study is to determine whether dietary supplements and shakes containing a combination of nutrients/ingredients individually shown in research studies to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Dietary supplement containing vitamins, minerals, and herbs, Shakes with nutrients and herbs and Personal energy tracking tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2007
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65 years of age.
- Body Mass Index (BMI) between 25-35
- Willing to stop taking any nutritional supplements
Who cannot join
- Currently taking weight loss medication or supplements
- Currently smoke
- Taking any prescription medications
- Experienced at least a 10 pound weight loss over the past 2 months.
- History of serious heart problems (i.e. heart attack, angina, bypass surgery).
- Diagnosed with diabetes (insulin or non-insulin dependent)
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- Known history of gastrointestinal diseases (i.e. Crohn's disease, chronic diarrhea, Inflammatory Bowel Disease)
- Undergone surgical procedure for weight loss (i.e. gastroplasty, gastric by-pass, gastrectomy, stomach stapling, gastric banding, etc).
- History of stroke or seizure activity
- Medical conditions known to affect serum lipids
- History of uncontrolled hypertension or with a current measured blood pressure with diastolic above 90 or systolic above 140 mm Hg
- A total serum cholesterol above 240 mg/dL
- Known HIV infection
- Known history of depression and currently taking anti-depression medications
- Treated for cancer in the last 5 years
- Known allergies to supplements
- Known history of eating disorder (i.e. bulimia, anorexia nervosa)
- Known severe swallowing disorders
- For females, known to be pregnant or breast-feeding or trying to become pregnant
- Participating in another clinical (medical or nutritional) study or likely to be enrolled in another medical or nutritional protocol during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Excessive body weight is becoming a concern around the world, for example over half of the American adult population is overweight or obese. The purpose of this study is to determine whether dietary supplements and shakes containing a combination of nutrients/ingredients individually shown in research studies to reduce hunger, enhance metabolism, reduce the body's ability to 'store' fat, and enhance energy, promote healthy body weight and composition over 12 weeks. A further study objective is to determine whether the inclusion of a personal, easy to use, energy tracking device for the measurement of daily energy intake and expenditure also helps with the promotion of healthy body weight and body composition.
In this prospective, blinded study 120 volunteers who meet the entrance criteria including a BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil supplement. Subjects will be randomly assigned to a control or experimental group and stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects in each strata across groups. A subset of subjects will also wear a personal energy tracking device. Subjects will be instructed how to incorporate the shakes and supplements into their current diet and encouraged to incorporate fruits, vegetables, whole grains, and other healthy foods into their current meals and to exercise at least 30 minutes five days per week.
- Conditions
- Overweight, Obesity
- Being tested
- Dietary supplement containing vitamins, minerals, and herbs, Shakes with nutrients and herbs, Control dietary supplement, Isocaloric, isonitrogenous control shakes without herbs, Personal energy tracking tool
- Keywords
- Overweight, Obese, Dietary Supplements, Shakes, Nutrition, Overweight and Obese Adults (BMI 25-35)
- Medical subject headings
- Overweight, Obesity, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement containing vitamins, minerals, and herbsBehavioural
Shakes with nutrients and herbsBehavioural
Control dietary supplementBehavioural
Isocaloric, isonitrogenous control shakes without herbsBehavioural
Personal energy tracking toolBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes
Measured: Several measurements over 12 weeks
Secondary outcomes (1)
Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements
Measured: Several measurements over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doug Burke, PhD, Principal investigator, Pharmanex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502658
- Sponsor's protocol ID
- 007-001, WIRB 20070167
- Status last verified
- Mar 2008
- First submitted
- 12 Jul 2007
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dietary Supplements (Shakes and Supplements) and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
- ClinicalTrials.gov ID
- NCT00502658
- Acronym / sponsor ID
- 007-001, WIRB 20070167
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obese, Dietary Supplements, Shakes, Nutrition, Overweight and Obese Adults (BMI 25-35)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Jul 2007 (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.
Excessive body weight is becoming a concern around the world, for example over half of the American adult population is overweight or obese. The purpose of this study is to determine whether dietary supplements and shakes containing a combination of nutrients/ingredients individually shown in research studies to reduce hunger, enhance metabolism, reduce the body's ability to 'store' fat, and enhance energy, promote healthy body weight and composition over 12 weeks. A further study objective is to determine whether the inclusion of a personal, easy to use, energy tracking device for the measurement of daily energy intake and expenditure also helps with the promotion of healthy body weight and body composition.
In this prospective, blinded study 120 volunteers who meet the entrance criteria including a BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil supplement. Subjects will be randomly assigned to a control or experimental group and stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects in each strata across groups. A subset of subjects will also wear a personal energy tracking device. Subjects will be instructed how to incorporate the shakes and supplements into their current diet and encouraged to incorporate fruits, vegetables, whole grains, and other healthy foods into their current meals and to exercise at least 30 minutes five days per week.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-65 years of age.
- Body Mass Index (BMI) between 25-35
- Willing to stop taking any nutritional supplements
Key exclusion criteria (20 listed)
- Currently taking weight loss medication or supplements
- Currently smoke
- Taking any prescription medications
- Experienced at least a 10 pound weight loss over the past 2 months.
- History of serious heart problems (i.e. heart attack, angina, bypass surgery).
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 containing vitamins, minerals, and herbs | Behavioural | – |
| Shakes with nutrients and herbs | Behavioural | – |
| Control dietary supplement | Behavioural | – |
| Isocaloric, isonitrogenous control shakes without herbs | Behavioural | – |
| Personal energy tracking tool | Behavioural | – |
Primary outcome
Body weight changes
Time frame: Several measurements over 12 weeks
1 secondary outcome
Biophotonic scanner score, blood chemistry and metabolic profiles, adverse events, subjects' supplement preference, quality of life measurements
Time frame: Several measurements over 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 28 Mar 2008.
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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.
Doug Burke, PhD principal investigator
Pharmanex
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 containing vitamins, minerals, and herbs, Shakes with nutrients and herbs and Personal energy tracking tool in people with Overweight and Obesity, run by Pharmanex 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 20 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 28 Mar 2008. 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. 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?
Body weight changes (time frame: Several measurements over 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 28 Mar 2008.