Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/02/2013
Date assigned
04/04/2013
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Isabel Covas

ORCID ID

Contact details

IMIM Institut Hospital del Mar d'Investigacions Mèdiques
Cardiovascular Risk and Nutrition Group
Dr. Aiguader
88
Barcelona
08003
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2006/2601/I/AGL2006-02031

Study information

Scientific title

Effect of AlKylGlycerols on angiogenic and inflammatory factors in Obese individuals: a randomized double-blind cross-over clinical supplementation trial

Acronym

AKGO

Study hypothesis

A rich alkylglycerol (AKG) preparation will be more effective on inflammatory markers than a low AKG preparation.

Ethics approval

Clinical Research Ethical Committe of the "Institut de Recerca Hospital del Mar (IMIM)", 25 February 2008, ref: 2006/2601/I

Study design

Randomized double-blind cross-over single centre clinical supplementation trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Community-dwelling obese participants with a body mass index (BMI) ≥30 kg/m2 to ≤40 kg/m2

Intervention

Randomized, double-blind, cross-over, single centre clinical supplementation trial, in which 24 subjects (12 men and 15 women) will be randomised to one of two orders of administration of:
1. High alcoxyglycerol content (HAC: 20 mg AKG/ 6 ml olive oil)
2. Low alcoxyglycerol content (LAC: 10 mg AKG/ 6 ml olive oil)

There will be in three intervention periods of 3 weeks separated by 2-week wash-out periods avoiding shark oil or AKG supplements.

Intervention type

Drug

Phase

Not Applicable

Drug names

Alkylglycerol from olive oil

Primary outcome measures

1. Inflammatory parameters measured at baseline and before and after each intervention:
1.1. Serum inmunoglobulines A, G, and M
1.2. Complement 3(C3) and 4 (C4)
1.3. Plasma interleukine-8 (IL8), monocyte chemotactic protein-1(MCP-1), and vascular endothelial growth factor (VEGF) .

Secondary outcome measures

Oxidative damage: Plasma lipids and lípid peroxides will be determined at baseline and 3 weeks after each intervention period.

Overall trial start date

02/05/2012

Overall trial end date

20/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese patients
2. Body mass index (BMI) ≥ 30 kg/m2 to ≤40 kg/m2
3. Aged 20 - 60 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Intake of antioxidant supplement or acetylsalicylic acid or any other drug with established antioxidative properties
2. Athletes with physical activity (PA >3000 kcal/day in leisure-time
3. BMI <30 kg/m2 or > 40 kg/m2)
4. Diabetes, multiple allergies, intestinal diseases
5. Any condition that limits the mobility of the subject making study visits impossible
6. Life threatening illness such as cancer or severe disease with a lowered expected 3 year survival
7. Any other disease or condition that would worsen the adherence to the measurements or treatment

Recruitment start date

02/05/2012

Recruitment end date

20/12/2012

Locations

Countries of recruitment

Spain

Trial participating centre

IMIM Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona
08003
Spain

Sponsor information

Organisation

Spanish Ministry of Economy and Competitiveness (Spain)

Sponsor details

MINECO
Former Spanish Ministry of Science and Technology
Secretaría General de Innovación
Albacete
5
Madrid
28027
Spain

Sponsor type

Government

Website

http://www.mineco.gob.es

Funders

Funder type

Government

Funder name

Spanish Ministry of Science and Technology (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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