NCT01934036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

August 9, 2013

Last Update Submit

February 24, 2014

Conditions

ObesityOverweight

Keywords

Weight lossNutritional supplementWaistBody compositionSkinfolds

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Two months of treatment and three months after concluded the treatment

  • To evaluate the effect of Obex on the arm circumference.

    Two months of treatment and three months after concluded the treatment

  • To evaluate the effect of Obex on the percentage of body fat

    Two months of treatment and three months after concluded the treatment

  • To evaluate the effect of Obex on the muscular mass

    Two months of treatments and three months after concluded the treatment

  • To evaluate the effect of Obex on arterial blood pressures.

    Two months of treatment and three months after concluded the treatment

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

ObexDIETARY_SUPPLEMENT

After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.

Obex, a nutritional supplement
PlaceboDRUG

After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.

Placebo

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Madrid

Ciudad Universitaria de Cantoblanco, Madrid, 28049, Spain

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Consuelo Prado, Ph.D.

    Universidad Autonónoma de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

September 4, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

ES(1)