Effect of AlKylGlycerols on angiogenic and inflammatory factors in Obese individuals
| ISRCTN | ISRCTN23803922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23803922 |
| Secondary identifying numbers | 2006/2601/I/AGL2006-02031 |
- 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
Scientific
IMIM Institut Hospital del Mar d'Investigacions Mèdiques
Cardiovascular Risk and Nutrition Group
Dr. Aiguader, 88
Barcelona
08003
Spain
Study information
| Study design | Randomized double-blind cross-over single centre clinical supplementation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Alkylglycerol from olive oil |
| Primary outcome measure | 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 study start date | 02/05/2012 |
| Completion date | 20/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
08003
Spain
Sponsor information
Spanish Ministry of Economy and Competitiveness (Spain)
Government
Government
MINECO
Former Spanish Ministry of Science and Technology
Secretaría General de Innovación
Albacete, 5
Madrid
28027
Spain
| Website | http://www.mineco.gob.es |
|---|
Funders
Funder type
Government
Spanish Ministry of Science and Technology (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
17/01/2019: Publication reference added
