Back to resultsImpact of Flaxseed on the Syndrome Metabolic Inflammation
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Flaxseed or rice raw powder ingestion
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring flaxseed, lignans, inflammation, Nutrition, enterolactone, enterodiol
Eligibility Criteria
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
Sites / Locations
- Clinical Hospital of Ribeirao Preto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control group
Flaxseed group
Rice and low carb group
Flaxssed and low carb group
Arm Description
In the group with 11 volunteers, the control group did no change in normal food intake.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02132728
Brief Title
Impact of Flaxseed on the Syndrome Metabolic Inflammation
Official Title
Flaxseed and Lignans: Effect of Consumption on Nutritional and Inflammatory Markers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
flaxseed, lignans, inflammation, Nutrition, enterolactone, enterodiol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the group with 11 volunteers, the control group did no change in normal food intake.
Arm Title
Flaxseed group
Arm Type
Experimental
Arm Description
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.
Arm Title
Rice and low carb group
Arm Type
Experimental
Arm Description
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.
Arm Title
Flaxssed and low carb group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flaxseed or rice raw powder ingestion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammatory markers and hormones blood levels
Description
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.
Time Frame
After 12-hour fast, in the first and 42th day of intervention
Secondary Outcome Measure Information:
Title
Blood lipid profile
Description
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.
Time Frame
After 12-hour fast, in the first and 42th day of intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio S Marchini, PhD
Organizational Affiliation
Ribeirão Preto Medical School. São Paulo University (USP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital of Ribeirao Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18495270
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.
Results Reference
background
PubMed Identifier
18460483
Citation
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.
Results Reference
background
PubMed Identifier
18252024
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.
Results Reference
background
PubMed Identifier
18502107
Citation
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.
Results Reference
background
PubMed Identifier
18775100
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.
Results Reference
background
PubMed Identifier
15777541
Citation
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.
Results Reference
background
PubMed Identifier
11849672
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. doi: 10.1016/s0021-9150(01)00603-7.
Results Reference
background
PubMed Identifier
21791166
Citation
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.
Results Reference
background
PubMed Identifier
25577201
Citation
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.
Results Reference
derived
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Impact of Flaxseed on the Syndrome Metabolic Inflammation
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