Weight LossNCT01423019
A Comparative Effectiveness Study Evaluating the Effects of Thermogenic Supplements on Body Composition
A study testing Advantra Z, Advantra Z + Naringin + Hesperiden and Sugar pill in people with Weight Loss, run by Integrative Health Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.) Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Advantra Z, Advantra Z + Naringin + Hesperiden and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2012
- 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
- Must ensure with medical provider that there are no medical conditions that would preclude participation
- Must be able to swallow capsules
- Must be age 21 or above
Who cannot join
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Health Technologies, Inc.
San Antonio, Texas, 78209
About this study
Official title: A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol
The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)
Read the detailed description
In a previous randomized double-blinded placebo-controlled pilot study, subjects taking the nutritional supplements contained in these two weight loss plans had a short-term statistically significant increase in their resting metabolic rates as compared to taking a placebo. No increases were found in blood pressure, resting heart rate, or self-reported discomfort when taking the supplement.
The current study was designed to extend the findings of the pilot study over a 60-day study period using a randomized double-blinded placebo-controlled protocol with the same weight loss interventions.
- Conditions
- Weight Loss
- Being tested
- Advantra Z, Advantra Z + Naringin + Hesperiden, Sugar pill
- Keywords
- Weight Loss, Body Composition, Fat Free Mass, Bone Mineral Density, Adipose Tissue, Dual-Energy X-Ray Absorptiometry, Body Fat, Eating and appetite control, Basal Metabolic Rate
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advantra ZDietary supplement
Also called p-synephrine
Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.
Advantra Z + Naringin + HesperidenDietary supplement
Also called Naringin, Hesperiden
Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden.
Sugar pillOther
Also called Placebo
Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
| Study group | Role | What they receive |
|---|---|---|
| Advantra Z | Active comparator | Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite Receives: Dietary Supplement: Advantra Z |
| Advantra Z + Naringin + Hesperiden | Active comparator | Not described Receives: Dietary Supplement: Advantra Z + Naringin + Hesperiden |
| Sugar pill | Placebo comparator | Capsule contains inert ingredient. Receives: Other: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions.
Measured: 0 and 60 days
Secondary outcomes (14)
43-item blood chemistry panel
43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP
Measured: 0 and 60 days
Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days
Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study.
Measured: 0 and 30 days
Change from Baseline in Resting Heart Rate at 30 days
Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study.
Measured: 0 and 30 days
Change from midpoint of study in Resting Heart Rate at 60 days
Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between day 30 and 60 of study.
Measured: 30 and 60 days
Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days
Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study.
Measured: 0 and 60 days
Change from Baseline in Resting Heart Rate at 60 days
Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study.
Measured: 0 and 60 days
Change from Baseline in self-reported quality of life at 30 days.
Measured: 0 and 30 days
Change from mid-point of study in self-reported quality of life at 60 days.
Measured: 30 and 60 days
Change from Baseline in self-reported quality of life at 60 days.
Measured: 0 and 60 days
Change from Baseline in self-reported eating behavior at 30 days.
A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
Measured: 0 and 30 days
Change from mid-point of study in self-reported eating behavior at 60 days
A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
Measured: 30 and 60 days
Change from Baseline in self-reported eating behavior at 60 days.
A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
Measured: 0 and 60 days
Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days
Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between mid-point and day 60 of study.
Measured: 30 and 60 days
Number of participants with adverse events
Participants will have opportunity to report on a daily basis any adverse events experienced.
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
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 Weight LossStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Gilbert R Kaats, Integrative Health Technologies, Inc.
- Investigators
- Gilbert R Kaats, PhD FACN, Principal investigator, Integrative Health Technologies, Inc.Harry G Preuss, MD MACN, Study chair, Georgetown University Medical Center, Departments of Biochemistry, Medicine and PathologySidney J Stohs, PhD, Study director, Dean Emeritus, Creighton University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423019
- Sponsor's protocol ID
- Nutratech - 60
- Status last verified
- Jan 2012
- First submitted
- 5 Jul 2011
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stohs SJ, Preuss HG, Keith SC, Keith PL, Miller H, Kaats GR. Effects of p-synephrine alone and in combination with selected bioflavonoids on resting metabolism, blood pressure, heart rate and self-reported mood changes. Int J Med Sci. 2011 Apr 28;8(4):295-301. doi: 10.7150/ijms.8.295.
PubMed 21537493
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol
- ClinicalTrials.gov ID
- NCT01423019
- Acronym / sponsor ID
- Nutratech - 60
- Conditions
- Weight Loss
- Keywords
- Weight Loss, Body Composition, Fat Free Mass, Bone Mineral Density, Adipose Tissue, Dual-Energy X-Ray Absorptiometry, Body Fat, Eating and appetite control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Aug 2011 (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.
The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)
Detailed description
In a previous randomized double-blinded placebo-controlled pilot study, subjects taking the nutritional supplements contained in these two weight loss plans had a short-term statistically significant increase in their resting metabolic rates as compared to taking a placebo. No increases were found in blood pressure, resting heart rate, or self-reported discomfort when taking the supplement.
The current study was designed to extend the findings of the pilot study over a 60-day study period using a randomized double-blinded placebo-controlled protocol with the same weight loss interventions.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advantra Z | Active comparator | Dietary Supplement: Advantra ZProprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite |
| Advantra Z + Naringin + Hesperiden | Active comparator | Dietary Supplement: Advantra Z + Naringin + Hesperiden |
| Sugar pill | Placebo comparator | Other: Sugar pillCapsule contains inert ingredient. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must ensure with medical provider that there are no medical conditions that would preclude participation
- Must be able to swallow capsules
- Must be age 21 or above
Key exclusion criteria (1 listed)
- Pregnant or breast feeding
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 |
|---|---|---|
| Advantra ZAlso: p-synephrineTwo capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine. | Dietary supplement | Advantra Z |
| Advantra Z + Naringin + HesperidenAlso: Naringin, HesperidenTwo capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden. | Dietary supplement | Advantra Z + Naringin + Hesperiden |
| Sugar pillAlso: PlaceboTwo capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals. | Other | Sugar pill |
Primary outcome
Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
Time frame: 0 and 60 days
This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions.
14 secondary outcomes
43-item blood chemistry panel
Time frame: 0 and 60 days
Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days
Time frame: 0 and 30 days
Change from Baseline in Resting Heart Rate at 30 days
Time frame: 0 and 30 days
Change from midpoint of study in Resting Heart Rate at 60 days
Time frame: 30 and 60 days
Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days
Time frame: 0 and 60 days
Change from Baseline in Resting Heart Rate at 60 days
Time frame: 0 and 60 days
Change from Baseline in self-reported quality of life at 30 days.
Time frame: 0 and 30 days
Change from mid-point of study in self-reported quality of life at 60 days.
Time frame: 30 and 60 days
Change from Baseline in self-reported quality of life at 60 days.
Time frame: 0 and 60 days
Change from Baseline in self-reported eating behavior at 30 days.
Time frame: 0 and 30 days
Change from mid-point of study in self-reported eating behavior at 60 days
Time frame: 30 and 60 days
Change from Baseline in self-reported eating behavior at 60 days.
Time frame: 0 and 60 days
Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days
Time frame: 30 and 60 days
Number of participants with adverse events
Time frame: up to 60 days
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 23 Jan 2012.
- Background: PubMed 21537493Stohs SJ, Preuss HG, Keith SC, Keith PL, Miller H, Kaats GR. Effects of p-synephrine alone and in combination with selected bioflavonoids on resting metabolism, blood pressure, heart rate and self-reported mood changes. Int J Med Sci. 2011 Apr 28;8(4):295-301. doi: 10.7150/ijms.8.295.
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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.
Gilbert R Kaats, PhD FACN principal investigator
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN study chair
Georgetown University Medical Center, Departments of Biochemistry, Medicine and Pathology
Sidney J Stohs, PhD study director
Dean Emeritus, Creighton University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advantra Z, Advantra Z + Naringin + Hesperiden and Sugar pill in people with Weight Loss, run by Integrative Health Technologies, Inc. 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 1 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 23 Jan 2012. 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?
Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA) (time frame: 0 and 60 days). 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 NCT01423019, 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 23 Jan 2012.