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Impact of Flaxseed on the Syndrome Metabolic Inflammation

U

University of Sao Paulo

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Other: Flaxseed or rice raw powder ingestion

Study type

Interventional

Funder types

Other

Identifiers

NCT02132728
HCRP 4244/2007

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

Male

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 4 patient groups

Control group
No Intervention group
Description:
In the group with 11 volunteers, the control group did no change in normal food intake.
Flaxseed group
Experimental group
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.
Treatment:
Other: Flaxseed or rice raw powder ingestion
Rice and low carb group
Experimental group
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.
Treatment:
Other: Flaxseed or rice raw powder ingestion
Flaxssed and low carb group
Experimental group
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.
Treatment:
Other: Flaxseed or rice raw powder ingestion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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