Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obesity is one of the most important health problems in Western countries. Strategies are needed to reduce body weight. This study will assess whether an EBC extract (African plant) works on the body weight and the lipid profile of obese or overweight people.

Who can participate?
Males and females between 20 and 55 without any documented cardiovascular problems and with a body mass index between 27.5 and 34.9 Kg/m2

What does the study involve?
Participants are randomly allocated to one of three groups: EBC extract 75 mg, EBC extract 150mg or a dummy extract (placebo). There is a first visit and 3 follow-up monthly visits.

What are the possible benefits and risks of participating?
The benefits of participating will be weight loss and no risks are expected.

Where is the study run from?
Hospital Clínic of Barcelona, Spain.

When is study starting and how long is it expected to run for?
The study started in May 2013 and is expected to run for a year.

Who is funding the study?
Biocentury (Spain).

Who is the main contact?
Dr. Ramon Estruch

Trial website

Contact information



Primary contact

Prof Ramon Estruch


Contact details

Hospital CLínic de Barcelona
c/Villarroel nº170
+34 93 2279365

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effects of three months ingestion of EBC extract on body weight and adiposity.


Study hypothesis

The benefit of the EBC extract will reduce at short term (3 months) body weight and fat body mass, as well as improve glucose metabolism parameters and lipid profile.

Ethics approval

This study has been approved by the Institutional Review Board of the Hospital Clínic of Barcelona.

Study design

Open randomized and double blind placebo-controlled clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Overweight and obesity


Subjects are randomized to three groups:
Group 1: Receives 4 capsules/day of placebo
Group 2: Receives 4 capsules/day of 75 mg each of EBC extract
Group 3: Receives 4 capsules/day of 150 mg each of EBC extract

Intervention type



Not Applicable

Drug names

EBC extract

Primary outcome measures

1. Changes in body weight and body mass index
2. Changes in waist perimeter
3. Changes in fat body mass and distribution of fat in the body measured by DEXA (Dual-energy X-ray Absorptiometry)

Secondary outcome measures

1. Medical record:
A complete medical record will be obtained from all participants, which included data on alcohol intake, smoking and dietary habits. Blood pressure and heart rate will be measured with an electronic apparatus Omron HEM-705CP (Netherlands).
2. Nutrition assessment, and general analyses :
All participants will complete 7-day dietary register during the week previous to the physical and laboratory assessment. We will assess the total quantity of calories ingested in the previous week as well as the proportion corresponding to carbohydrates, lipids and proteins by using the Food Processor Nutrition & Fitness software (esha RESEARCH, Salem, OR, USA) . Overall nutrition will be determined by percentage of ideal weight, lean body mass and body mass index. Waist Perimeter will be measured. The proteic nutrition will be determined on the basis of the following parameters: hemoglobin, total lymphocyte count, total proteins, albumin, prealbumin, transferrin and retinol-binding protein. Serum and intraerythrocytary folic acid concentrations will be measured, as well as serum vitamin A, B1, B12, C, E, B-carotenes, Zn, Mg and Se concentrations. Moreover, the following measurements will also be obtained: red blood cell count, hematocrit, mean corpuscular volume, leukocyte count, glucose, creatinine, electrolytes, uric acid, transaminases, lactate dehydrogenase, alkaline phosphatase, gammaglutamyl transpeptidase and bilirrubin. Physical activity will be measured using the Minnesota Leisure Time Physical Activity Questionnaire.
3. Plasma glucose and insulin concentration and Homeostasis Model Assessment (HOMA) will be determined.
4. Serum lipoproteins and others:
Total cholesterol, triglycerides, cHDL, cLDL, Apo A1, Apo B, and lipoprotein (a) will be determined.
5. Diet and exercise monitoring:
All participants will follow an isocaloric diet prepared according to their personal preferences. The diet will be strictly monitored during the study. Diet compliance will be assessed from 7-days diet records administered before each evaluation. This assessment will be administered by trained personnel. The foods ingested will be converted into nutritional values with the aid of the Professional Diet Balancer software (Cardinal Health Systems, Inc., Edina, MN). Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain. Control of the diet and physical exercise will be carried out before and after each intervention, the same day on which the clinical examinations are performed and blood is withdrawn for immunologic studies.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Males and females between 20 and 55 years old without documented cardiovascular disease (ischemic heart disease – angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) and who have a body mass index between 27.5 and 34.9 Kg/m2.

Participant type


Age group




Target number of participants

120 participants (60 men and 60 women)

Participant exclusion criteria

Subjects with a previous history of cardiovascular disease (ischemic heart disease – angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease), any severe chronic disease, alcoholism or other toxic abuse will be excluded, as well as those subjects who had taken drugs or followed dietary interventions with potential effects on body weight in the last three months. Subjects who had changed their weight +/-3 kg in the last 3 months were also excluded from the study.

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital CLínic de Barcelona

Sponsor information


Biocentury SLU (Spain)

Sponsor details

Ctra. N-II km 71417242 Quart

Sponsor type




Funder type


Funder name

Biocentury SLU (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes