Impact of Flaxseed on the Syndrome Metabolic Inflammation

NCT02132728 | Completed

• 1 other identifier: HCRP 4244/2007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Keywords

flaxseed; lignans; inflammation; Nutrition; enterolactone; enterodiol

Outcome Measures

Primary Outcomes (1)

• 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-α), 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

Secondary Outcomes (1)

• Blood lipid profile

  After 12-hour fast, in the first and 42th day of intervention

Study Arms (4)

Control group

NO INTERVENTION

In the group with 11 volunteers, the control group did no change in normal food intake.

Flaxseed group

EXPERIMENTAL

In this group with 14 volunteers, they received 50% carbohydrate, 31% fat, 19% protein and 60 g of flaxseed powder / day during the period of study.

Other: Flaxseed or rice raw powder ingestion

Rice and low carb group

EXPERIMENTAL

In this group with 13 volunteers, they received 35% carbohydrate, 46% fat, 19% protein and 60g of raw rice powder / day during the period of study.

Other: Flaxseed or rice raw powder ingestion

Flaxssed and low carb group

EXPERIMENTAL

In this group with 14 volunteers, they received 32% carbohydrate, 47% fat, 21% protein and 60 g of flaxseed powder / day during the period of study.

Other: Flaxseed or rice raw powder ingestion

Interventions

Flaxseed or rice raw powder ingestion OTHER

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.

Flaxseed group; Flaxssed and low carb group; Rice and low carb group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Female gender

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (9)

• 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.

  PMID: 18495270 BACKGROUND

• 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. doi: 10.1080/07315724.2008.10719676.

  PMID: 18460483 BACKGROUND

• 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.

  PMID: 18252024 BACKGROUND

• Hallund J, Tetens I, Bugel 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.

  PMID: 18502107 BACKGROUND

• 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.

  PMID: 18775100 BACKGROUND

• Prasad K. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis. 2005 Apr;179(2):269-75. doi: 10.1016/j.atherosclerosis.2004.11.012. Epub 2005 Jan 26.

  PMID: 15777541 BACKGROUND

• 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. doi: 10.1016/s0021-9150(01)00603-7.

  PMID: 11849672 BACKGROUND

• Prim CR, Baroncini LA, Precoma LB, Caron PH, Winter G, Poletti MO, Precoma 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.

  PMID: 21791166 BACKGROUND

• Cassani RS, Fassini PG, Silvah JH, Lima CM, Marchini JS. Impact of weight loss diet associated with flaxseed on inflammatory markers in men with cardiovascular risk factors: a clinical study. Nutr J. 2015 Jan 10;14:5. doi: 10.1186/1475-2891-14-5.

  PMID: 25577201 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Julio S Marchini, PhD

  Ribeirão Preto Medical School. São Paulo University (USP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Flaxseed and lignans: effect of consumption on nutritional and inflammatory markers

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: March 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

BR (1)