Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2013-01-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment
NCT02201758
Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
NCT02179372
Diet Study on Ulcerative Colitis
NCT04147598
Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group
NCT00805428
Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease
NCT02349594
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
palmitoleic acid
Palmitoleic acid: 720 mg/day for 56 days
Palmitoleic acid
Palmitoleic acid and 5-ASA
Sugar pill
Sugar pill: 720 mg/day for 56 days
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Palmitoleic acid
Palmitoleic acid and 5-ASA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* With mild and moderate disease.
* Patients treated with only doses of 5-aminosalicylates (5-ASA)
* BMI, 18 to 34.9 kg/m2
* Born in Mexico the last two generations
* Each patient will be asked to sign and date the consent form, to indicate that you agree to participate.
Exclusion Criteria
* With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
* If the patient use drugs that inhibit fat absorption.
* Patients after partial or total resection of stomach or small intestine.
* Steroid users.
* Patients in remission histology, clinical and endoscopic.
* Patients treated with FAn-3,6 or 9.
18 Years
59 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jesús Kazuo Yamamoto Furusho
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jesús K Yamamoto, MD, PhD
Role: STUDY_DIRECTOR
Inflammatory Bowel Disease Clinic
Nallely Bueno, MSc
Role: PRINCIPAL_INVESTIGATOR
Inflammatory Bowel Disease Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
INCMNSZ
DF, Tlalpan, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Bueno-Hernandez N, Sanchez-Munoz F, Barreto-Zuniga R, Dominguez-Lopez A, Yamamoto-Furusho JK. Expression of HNF4gamma is downregulated in patients with active ulcerative colitis (UC) compared to UC patients in remission and healthy controls. Inflamm Bowel Dis. 2011 Aug;17(8):E91. doi: 10.1002/ibd.21753. Epub 2011 May 25. No abstract available.
Drewes T, Senkel S, Holewa B, Ryffel GU. Human hepatocyte nuclear factor 4 isoforms are encoded by distinct and differentially expressed genes. Mol Cell Biol. 1996 Mar;16(3):925-31. doi: 10.1128/MCB.16.3.925.
Gruber L, Lichti P, Rath E, Haller D. Nutrigenomics and nutrigenetics in inflammatory bowel diseases. J Clin Gastroenterol. 2012 Oct;46(9):735-47. doi: 10.1097/MCG.0b013e31825ca21a.
Daigo K, Kawamura T, Ohta Y, Ohashi R, Katayose S, Tanaka T, Aburatani H, Naito M, Kodama T, Ihara S, Hamakubo T. Proteomic analysis of native hepatocyte nuclear factor-4alpha (HNF4alpha) isoforms, phosphorylation status, and interactive cofactors. J Biol Chem. 2011 Jan 7;286(1):674-86. doi: 10.1074/jbc.M110.154732. Epub 2010 Nov 3.
Nieto N, Torres MI, Rios A, Gil A. Dietary polyunsaturated fatty acids improve histological and biochemical alterations in rats with experimental ulcerative colitis. J Nutr. 2002 Jan;132(1):11-9. doi: 10.1093/jn/132.1.11.
Nishida T, Miwa H, Shigematsu A, Yamamoto M, Iida M, Fujishima M. Increased arachidonic acid composition of phospholipids in colonic mucosa from patients with active ulcerative colitis. Gut. 1987 Aug;28(8):1002-7. doi: 10.1136/gut.28.8.1002.
Ahn SH, Shah YM, Inoue J, Morimura K, Kim I, Yim S, Lambert G, Kurotani R, Nagashima K, Gonzalez FJ, Inoue Y. Hepatocyte nuclear factor 4alpha in the intestinal epithelial cells protects against inflammatory bowel disease. Inflamm Bowel Dis. 2008 Jul;14(7):908-20. doi: 10.1002/ibd.20413.
Taraviras S, Mantamadiotis T, Dong-Si T, Mincheva A, Lichter P, Drewes T, Ryffel GU, Monaghan AP, Schutz G. Primary structure, chromosomal mapping, expression and transcriptional activity of murine hepatocyte nuclear factor 4gamma. Biochim Biophys Acta. 2000 Jan 31;1490(1-2):21-32. doi: 10.1016/s0167-4781(99)00232-8.
Watanabe T, Kobunai T, Toda E, Kanazawa T, Kazama Y, Tanaka J, Tanaka T, Yamamoto Y, Hata K, Kojima T, Yokoyama T, Konishi T, Okayama Y, Sugimoto Y, Oka T, Sasaki S, Ajioka Y, Muto T, Nagawa H. Gene expression signature and the prediction of ulcerative colitis-associated colorectal cancer by DNA microarray. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):415-20. doi: 10.1158/1078-0432.CCR-06-0753.
Wille JJ, Kydonieus A. Palmitoleic acid isomer (C16:1delta6) in human skin sebum is effective against gram-positive bacteria. Skin Pharmacol Appl Skin Physiol. 2003 May-Jun;16(3):176-87. doi: 10.1159/000069757.
Wisely GB, Miller AB, Davis RG, Thornquest AD Jr, Johnson R, Spitzer T, Sefler A, Shearer B, Moore JT, Miller AB, Willson TM, Williams SP. Hepatocyte nuclear factor 4 is a transcription factor that constitutively binds fatty acids. Structure. 2002 Sep;10(9):1225-34. doi: 10.1016/s0969-2126(02)00829-8.
Okuma Y, Shirao T, Sakamoto A. [Constipation in intracranial diseases--correlation betweeen the cerebrospinal fluid pressure and constipation]. Saishin Igaku. 1971 Jan;26(1):139-44. No abstract available. Japanese.
Wu F, Dassopoulos T, Cope L, Maitra A, Brant SR, Harris ML, Bayless TM, Parmigiani G, Chakravarti S. Genome-wide gene expression differences in Crohn's disease and ulcerative colitis from endoscopic pinch biopsies: insights into distinctive pathogenesis. Inflamm Bowel Dis. 2007 Jul;13(7):807-21. doi: 10.1002/ibd.20110.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REF453
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.