Back to resultsObex, a Nutritional Supplement, in Overweight and Obese Spanish Women
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Obex
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Universidad Autónoma de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Obex, a nutritional supplement
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
To evaluate the effect of Obex on the arm circumference.
The arm circumference will be measured at baseline and at the end of 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
To evaluate the effect of Obex on the muscular mass
The muscular mass will be measured at baseline and at the end of 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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01934036
Brief Title
Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
Official Title
Efficacy and Safety of Obex®, a Nutritional Supplement, in Overweight or Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obex, a nutritional supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Obex
Intervention Description
After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.
Primary Outcome Measure Information:
Title
To evaluate the effect of OBEX on skinfolds
Description
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.
Time Frame
Two months of treatment and three months after concluded the treatment
Secondary Outcome Measure Information:
Title
To evaluate the effect of OBEX on the waist and hip circumferences
Description
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
Time Frame
Two months of treatment and three months after concluded the treatment
Title
To evaluate the effect of Obex on the arm circumference.
Description
The arm circumference will be measured at baseline and at the end of treatment.
Time Frame
Two months of treatment and three months after concluded the treatment
Title
To evaluate the effect of Obex on the percentage of body fat
Description
Body fat (%) will be assessed at baseline and the end of treatment
Time Frame
Two months of treatment and three months after concluded the treatment
Title
To evaluate the effect of Obex on the muscular mass
Description
The muscular mass will be measured at baseline and at the end of treatment.
Time Frame
Two months of treatments and three months after concluded the treatment
Title
To evaluate the effect of Obex on arterial blood pressures.
Description
The arterial BP will be evaluated at baseline and at the end of treatment.
Time Frame
Two months of treatment and three months after concluded the treatment
Title
To evaluate the effect of Obex on fasting glucose and cholesterol levels
Description
The fasting glucose and cholesterol levels will be evaluated at baseline and at the end of treatment.
Time Frame
Two months of treatment and three months after concluded the treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Consuelo Prado, Ph.D.
Organizational Affiliation
Universidad Autonónoma de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Autónoma de Madrid
City
Ciudad Universitaria de Cantoblanco
State/Province
Madrid
ZIP/Postal Code
28049
Country
Spain
12. IPD Sharing Statement
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Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
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