Impact of Flaxseed on the Syndrome Metabolic Inflammation

Metabolic Syndrome Clinical Trial

Official title:

Flaxseed and Lignans: Effect of Consumption on Nutritional and Inflammatory Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132728
• Other study ID #: HCRP 4244/2007
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: May 21, 2014
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and inflammatory indicators in male workers of a food industry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Work in the manufacturing company in the city of Itu-SP.

• Have at least three of the following cardiovascular risk factors: waist circumference = 90 cm; overweight or obese characterized by BMI = 25 kg/m²; fasting total cholesterol = 200 mg/dL, LDL- cholesterol = 130 mg/dL and HDL-cholesterol < 40 mg/dL, triglycerides = 150 mg/dL; glycemia =100 mg/dL; and hypertension characterized by systolic blood pressure =140 mm/Hg and/or diastolic blood pressure = 90 mm/Hg.

Exclusion Criteria:

• Female gender

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Flaxseed or rice raw powder ingestion
The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Ribeirao Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. — View Citation

Fukumitsu S, Aida K, Ueno N, Ozawa S, Takahashi Y, Kobori M. Flaxseed lignan attenuates high-fat diet-induced fat accumulation and induces adiponectin expression in mice. Br J Nutr. 2008 Sep;100(3):669-76. doi: 10.1017/S0007114508911570. Epub 2008 Feb 6. — View Citation

Hallund J, Tetens I, Bügel S, Tholstrup T, Bruun JM. The effect of a lignan complex isolated from flaxseed on inflammation markers in healthy postmenopausal women. Nutr Metab Cardiovasc Dis. 2008 Sep;18(7):497-502. doi: 10.1016/j.numecd.2007.05.007. Epub 2008 May 23. — View Citation

Pan A, Demark-Wahnefried W, Ye X, Yu Z, Li H, Qi Q, Sun J, Chen Y, Chen X, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement on C-reactive protein, IL-6 and retinol-binding protein 4 in type 2 diabetic patients. Br J Nutr. 2009 Apr;101(8):1145-9. doi: 10.1017/S0007114508061527. — View Citation

Prasad K. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis. 2005 Apr;179(2):269-75. Epub 2005 Jan 26. — View Citation

Prim CR, Baroncini LA, Précoma LB, Caron PH, Winter G, Poletti MO, Précoma DB. Effects of linseed consumption for a short period of time on lipid profile and atherosclerotic lesions in rabbits fed a hypercholesterolaemic diet. Br J Nutr. 2012 Mar;107(5):660-4. doi: 10.1017/S0007114511003539. Epub 2011 Jul 27. — View Citation

Sugiura K, Tamakoshi K, Yatsuya H, Otsuka R, Wada K, Matsushita K, Kondo T, Hotta Y, Mitsuhashi H, Murohara T, Toyoshima H. Contribution of adipocytokines to low-grade inflammatory state as expressed by circulating C-reactive protein in Japanese men: comparison of leptin and adiponectin. Int J Cardiol. 2008 Nov 12;130(2):159-64. doi: 10.1016/j.ijcard.2008.01.006. Epub 2008 May 20. — View Citation

Vanharanta M, Voutilainen S, Nurmi T, Kaikkonen J, Roberts LJ, Morrow JD, Adlercreutz H, Salonen JT. Association between low serum enterolactone and increased plasma F2-isoprostanes, a measure of lipid peroxidation. Atherosclerosis. 2002 Feb;160(2):465-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers and hormones blood levels	For detection of insulin by chemiluminescence, we used the IMMULITE 1000® SYSTEMS - SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS (SIEMENS) (Los Angeles, USA).; The determination of ultra-sensitive CRP (C-reactive protein) by immunoturbidimetric assay was performed with the COBAS® MIRAPLUS - ROCHE (USA). The Tumor Necrosis Factor (TNF-a), leptin, and adiponectin were measured by enzyme immunoassay method, using kits of LINCOPLEX-LUMINEX®, manufactured by Millipore Corporation (USA). Determination of 8-Iso-Prostaglandin F2a (serum isoprostane) was performed by enzyme immunoassay with ASSAYS® DESIGNS kit, Inco, USA.	After 12-hour fast, in the first and 42th day of intervention	No
Secondary	Blood lipid profile	The determination of total cholesterol, high density lipoprotein (HDL-c), triglyceride, glucose and uric acid was performed by enzymatic method, with HITACHI® 912 - ROCHE (Japan). The reagent used for measurement of total cholesterol and triglyceride was CHOD-PAP, ROCHE (Japan); for HDL-c: Bioclin K071 (Japan); for glucose: GOD-PAD (Roche) (Japan); and for uric acid was Uric Acid Plus (URICASE) (Japan). To determine the values of low density lipoprotein (LDL-c) the Friedewald Formula was used.	After 12-hour fast, in the first and 42th day of intervention	No

External Links

•   Website of the Clinical Hospital of the Ribeirão Preto Medical School.