Effect of AlKylGlycerols on angiogenic and inflammatory factors in Obese individuals

ISRCTN	ISRCTN23803922
DOI	https://doi.org/10.1186/ISRCTN23803922
Protocol serial number	2006/2601/I/AGL2006-02031
Sponsor	Spanish Ministry of Economy and Competitiveness (Spain)
Funder	Spanish Ministry of Science and Technology (Spain)

Submission date: 20/02/2013
Registration date: 04/04/2013
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maria Isabel Covas
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomized double-blind cross-over single centre clinical supplementation trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of AlKylGlycerols on angiogenic and inflammatory factors in Obese individuals: a randomized double-blind cross-over clinical supplementation trial
Study acronym	AKGO
Study objectives	A rich alkylglycerol (AKG) preparation will be more effective on inflammatory markers than a low AKG preparation.
Ethics approval(s)	Clinical Research Ethical Committe of the "Institut de Recerca Hospital del Mar (IMIM)", 25 February 2008, ref: 2006/2601/I
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Alkylglycerol from olive oil
Primary outcome measure(s)	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) .
Key secondary outcome measure(s)	Oxidative damage: Plasma lipids and lípid peroxides will be determined at baseline and 3 weeks after each intervention period.
Completion date	20/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	24
Key inclusion criteria	1. Obese patients 2. Body mass index (BMI) ≥ 30 kg/m2 to ≤40 kg/m2 3. Aged 20 - 60 years, either sex
Key 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
Date of first enrolment	02/05/2012
Date of final enrolment	20/12/2012

Locations

Countries of recruitment

Spain

Study participating centre

IMIM Institut Hospital del Mar d'Investigacions Mèdiques

Barcelona
08003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2016	17/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/01/2019: Publication reference added