OverweightLyzme5NCT01634646
Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man
A study testing Lyzme5 in people with Overweight and Elevated Cholesterol, run by Jeff Golini at 1 site in United States.
Trial summary
This observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Elevated Cholesterol
- What is being tested?
- Lyzme5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years of age or older;
- Able to read, understanding, and signing a consent form;
- Not pregnant or breast feeding (female only);
- Have normal bio-markers for liver and kidney function (determined by blood test);
- Being at least 15 lbs over your ideal weight as defined by the Body Mass Index [BMI] chart;
- Have a total cholesterol level of or in excess of 200 mg/dl (determined by blood test);
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- Not using any illegal substances, including marijuana (medicinal or otherwise);
- Not using any "recreational drugs"
- Weighing less than 300 lbs
Who cannot join
- Under 21 years of age;
- Mentally impaired;
- Pregnant or breast feeding;
- A diabetic;
- Having digestion problems;
- Problems with kidneys, heart, or liver;
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- Having, or have had cancer;
- Taking a prescription;
- Weight of 300 lbs or over;
- Total cholesterol under 200 mg/dl;
- Using "recreational" drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
All American Pharmaceutical and Natural Foods Corporation
Billings, Montana, 59105
About this study
Official title: A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man
This observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man.
Read the detailed description
Lyzme5 is a nutritional supplement, according to the Dietary Supplement Health and Education Act (DSHEA) of 1994. It is composed of B Vitamins along with a non-essential amino acid. The individual components of this supplement are individually Generally Recognized as Safe (have GRAS status). The manufacturer's objective was to create a nutritional supplement that would have the potential to positively impact body weight, and possibly one or more lipid value (i.e., total cholesterol, LDL, triglycerides)as well, in overweight individuals who may also have minimally elevated cholesterol levels.
This observational clinical study will seek to recruit 100 volunteers in order to observe whether or not the weight-loss potential of Lyzme5, previously observed earlier in three volunteers, can be duplicated within a larger group.
The second objective is to establish whether or not Lyzme5 can positively impact cholesterol levels in man.
- Conditions
- Overweight, Elevated Cholesterol
- Being tested
- Lyzme5
- Keywords
- Observational study
- Medical subject headings
- Overweight, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyzme5Dietary supplement
Dietary Supplement (or placebo):
Lyzme5 (or the placebo) is to be mixed with 4 fluid ounces of a sugar free flavored drink (example: kool aid, crystal light, flavored tea drink, etc.).
Week one:
A single serving of the assigned material (Lyzme5 or the placebo) each day, 20 minutes before breakfast;
Week two:
Two (2) servings of the assigned material each day - the first, 20 minutes before breakfast and the second 20 minutes before the noon meal;
Week three through the end of the study:
Three (3) servings per day of the assigned material - the first, 20 minutes before breakfast, the second, 20 minutes before the noon meal, and the third, 20 minutes before the last meal of the day.
| Study group | Role | What they receive |
|---|---|---|
| Overweight, elevated total cholesterol | Placebo comparator | All individuates enrolled in this study are at least 15 lbs over their ideal weight as described on a BMI chart. Each individual must also have a total cholesterol of at least 200 mg/dl, or higher. Receives: Dietary Supplement: Lyzme5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed.
Measured: 60 days post initiation
Secondary outcomes (1)
Cholesterol reduction
The following will be assessed at enrollment, after 30 days, and at the conclusion of the volunteer's 60 day participation: Total cholesterol, HDL, LDL, and triglyceride levels.
Measured: 60 days post initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Unable to recruit sufficient local qualifying volunteers for study.
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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeff Golini
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- All American Pharmaceutical
- Responsible party
- Sponsor-investigator, Jeff Golini, All American Pharmaceutical
- Investigators
- Jeff Golini, Principal investigator, All American Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634646
- Sponsor's protocol ID
- Lyzme5-IRB26715/1
- Acronym
- Lyzme5
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man
- ClinicalTrials.gov ID
- NCT01634646
- Acronym / sponsor ID
- Lyzme5 / Lyzme5-IRB26715/1
- Conditions
- Overweight, Elevated Cholesterol
- Keywords
- Observational study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient local qualifying volunteers for study.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jeff GoliniIndustry (pharma, biotech, devices)
- Collaborators
- All American Pharmaceutical
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Jul 2012 (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 observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man.
Detailed description
Lyzme5 is a nutritional supplement, according to the Dietary Supplement Health and Education Act (DSHEA) of 1994. It is composed of B Vitamins along with a non-essential amino acid. The individual components of this supplement are individually Generally Recognized as Safe (have GRAS status). The manufacturer's objective was to create a nutritional supplement that would have the potential to positively impact body weight, and possibly one or more lipid value (i.e., total cholesterol, LDL, triglycerides)as well, in overweight individuals who may also have minimally elevated cholesterol levels.
This observational clinical study will seek to recruit 100 volunteers in order to observe whether or not the weight-loss potential of Lyzme5, previously observed earlier in three volunteers, can be duplicated within a larger group.
The second objective is to establish whether or not Lyzme5 can positively impact cholesterol levels in man.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight, elevated total cholesterol | Placebo comparator | Dietary Supplement: Lyzme5All individuates enrolled in this study are at least 15 lbs over their ideal weight as described on a BMI chart. Each individual must also have a total cholesterol of at least 200 mg/dl, or higher. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 21 years of age or older;
- Able to read, understanding, and signing a consent form;
- Not pregnant or breast feeding (female only);
- Have normal bio-markers for liver and kidney function (determined by blood test);
- Being at least 15 lbs over your ideal weight as defined by the Body Mass Index [BMI] chart;
Key exclusion criteria (11 listed)
- Under 21 years of age;
- Mentally impaired;
- Pregnant or breast feeding;
- A diabetic;
- Having digestion problems;
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 |
|---|---|---|
| Lyzme5Dietary Supplement (or placebo): Lyzme5 (or the placebo) is to be mixed with 4 fluid ounces of a sugar free flavored drink (example: kool aid, crystal light, flavored tea drink, etc.). Week one: A single serving of the assigned material (Lyzme5 or the placebo) each day, 20 minutes before breakfast; Week two: Two (2) servings of the assigned material each day - the first, 20 minutes before breakfast and the second 20 minutes before the noon meal; Week three through the end of the study: Three (3) servings per day of the assigned material - the first, 20 minutes before breakfast, the second, 20 minutes before the noon meal, and the third, 20 minutes before the last meal of the day. | Dietary supplement | Overweight, elevated total cholesterol |
Primary outcome
Weight loss
Time frame: 60 days post initiation
Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed.
1 secondary outcome
Cholesterol reduction
Time frame: 60 days post initiation
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient local qualifying volunteers for study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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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.
Jeff Golini principal investigator
All American Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyzme5 in people with Overweight and Elevated Cholesterol, run by Jeff Golini 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 Jul 2013. 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 was stopped early (reason given: Unable to recruit sufficient local qualifying volunteers for 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 loss (time frame: 60 days post initiation). 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 16 Jul 2013.