ObesityPhase 2/3NCT01934036
Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
A Phase 2/3 study testing Obex in people with Obesity and Overweight, run by Catalysis SL at 1 site in Spain.
Trial summary
The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Obex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 2/3
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 35 and 60 years.
- Body Mass Index (BMI) greater than 27 kg/m² and lower than 35 kg/m²
- Ability to provide informed consent
Who cannot join
- Presence of any endocrine, hepatic, renal or cardiovascular disease.
- History of bariatric surgery
- Pregnancy or lactation
- Concomitant disease with reduced life expectancy
- Severe psychiatric conditions
- Drug dependence
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Autónoma de Madrid
Ciudad Universitaria de Cantoblanco, Madrid, 28049
About this study
Official title: Efficacy and Safety of Obex®, a Nutritional Supplement, in Overweight or Obese Women
The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese.
Read the detailed description
The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata, Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.
- Conditions
- Obesity, Overweight
- Being tested
- Obex, Placebo
- Keywords
- Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObexDietary supplement
After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.
PlaceboDrug
After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Obex, a nutritional supplement | Experimental | Obex will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. Receives: Dietary Supplement: Obex |
| Placebo | Placebo comparator | Placebo will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of OBEX on skinfolds
The primary outcome is to evaluate the effect of the treatment with OBEX on skinfold thickness of the biceps, triceps, subscapular and suprailiac as compared to placebo group at 2 months of treatment.
Measured: Two months of treatment and three months after concluded the treatment
Secondary outcomes (6)
To evaluate the effect of OBEX on the waist and hip circumferences
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
Measured: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the arm circumference.
The arm circumference will be measured at baseline and at the end of treatment.
Measured: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the percentage of body fat
Body fat (%) will be assessed at baseline and the end of treatment
Measured: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the muscular mass
The muscular mass will be measured at baseline and at the end of treatment.
Measured: Two months of treatments and three months after concluded the treatment
To evaluate the effect of Obex on arterial blood pressures.
The arterial BP will be evaluated at baseline and at the end of treatment.
Measured: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on fasting glucose and cholesterol levels
The fasting glucose and cholesterol levels will be evaluated at baseline and at the end of treatment.
Measured: Two months of treatment and three months after concluded the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Consuelo Prado, Ph.D., Principal investigator, Universidad Autonónoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934036
- Sponsor's protocol ID
- HOPE_TRIAL1
- Status last verified
- Feb 2014
- First submitted
- 9 Aug 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Obex®, a Nutritional Supplement, in Overweight or Obese Women
- ClinicalTrials.gov ID
- NCT01934036
- Acronym / sponsor ID
- HOPE_TRIAL1
- Conditions
- Obesity, Overweight
- Keywords
- Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Sep 2013 (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 aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese.
Detailed description
The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata, Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obex, a nutritional supplement | Experimental | Dietary Supplement: ObexObex will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged between 35 and 60 years.
- Body Mass Index (BMI) greater than 27 kg/m² and lower than 35 kg/m²
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Presence of any endocrine, hepatic, renal or cardiovascular disease.
- History of bariatric surgery
- Pregnancy or lactation
- Concomitant disease with reduced life expectancy
- Severe psychiatric conditions
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 |
|---|---|---|
| ObexAfter concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex. | Dietary supplement | Obex, a nutritional supplement |
| PlaceboAfter concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo. | Drug | Placebo |
Primary outcome
To evaluate the effect of OBEX on skinfolds
Time frame: Two months of treatment and three months after concluded the treatment
The primary outcome is to evaluate the effect of the treatment with OBEX on skinfold thickness of the biceps, triceps, subscapular and suprailiac as compared to placebo group at 2 months of treatment.
6 secondary outcomes
To evaluate the effect of OBEX on the waist and hip circumferences
Time frame: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the arm circumference.
Time frame: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the percentage of body fat
Time frame: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the muscular mass
Time frame: Two months of treatments and three months after concluded the treatment
To evaluate the effect of Obex on arterial blood pressures.
Time frame: Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on fasting glucose and cholesterol levels
Time frame: Two months of treatment and three months after concluded the treatment
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 25 Feb 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.
Consuelo Prado, Ph.D. principal investigator
Universidad Autonónoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Obex in people with Obesity and Overweight, run by Catalysis SL at 1 site in Spain.
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 6 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 25 Feb 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 Spain. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the effect of OBEX on skinfolds (time frame: Two months of treatment and three months after concluded the treatment). 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 25 Feb 2014.