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Completed

NCT Number: NCT03211754

Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet

In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study consists of a diet-intervention in a single group under-free-living conditions. The diet was enriched with 15g of almonds and 15g of walnuts per day for eight weeks, supplied directly to the patient by the researcher. This amounts of walnuts and almonds contain polyunsaturated fatty acids of approximately 2.02g of omega 3 (alpha-linolenic acid) and 11.1g of omega 6 (linoleic acid) mostly. In a period of 14 months, the investigators recruited forty-eight sedentary subjects of 30 to 50 years old, and body mass index between 30 and 34.9 kg/m2, without evidence of chronic degenerative, infectious or neoplastic diseases, neither medication nor actually dietary treatment, and a physical level of exercise < 2 hours/week. All participants gave their written informed consent to participate in the study. The study was approved by the Institutional Ethics Committee of the Universidad de Guanajuato.

Collected data included the clinical-nutritional history, 24-hour recalls, and the International Physical Activity Questionnaire was applied to evaluate if subjects were sedentary. The dietary intake evaluation was estimated in kilocalories/day, the amount and type of macronutrients according to the database of United States Department of Agriculture and the National Institute of Public Health (Mexico). In order to evaluate adherence to the diet, volunteers were visited every two weeks to carry out three 24-hour recalls (two on weekdays and one on weekends). Positive Adherence to the diet plan was considered when the food consumption, walnuts and almonds were not modified more than ± 20% of the amount indicated by the researcher.

The investigators recorded the anthropometric measures, body composition, and measured serum glucose, lipid profile, insulin, lipocalin 2, high sensitivity C-reactive protein, adiponectin, and fatty acids profile, which were analyzed at the baseline and after dietary intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obesity grade I

Exclusion criteria

  • Subjects did not have evidence of chronic degenerative, infectious or neoplastic disease.
  • Lack of adherence to the diet and consumption of walnuts and almonds

Treatment and study plan

walnuts and almonds

Dietary Supplement

The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks

Primary outcomes

  1. Metabolics Changes

    Time frame: 8 weeks

    fatty acids in percentage

Secondary outcomes

  1. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    Weight in kilograms

  2. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    height in meters

  3. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    waist circumference in centimeters

  4. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    hip circumference in centimeters

  5. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    fat mass in percentage

  6. Significant decreases on all adiposity measures

    Time frame: 8 weeks

    Weight and height will be combined to report BMI in kg/m2

  7. Metabolics Changes

    Time frame: 8 weeks

    Glucose in mg/dL

  8. Metabolics Changes

    Time frame: 8 weeks

    total Cholesterol in mg/dL

  9. Metabolics Changes

    Time frame: 8 weeks

    LDL-cholesterol in mg/dL

  10. Metabolics Changes

    Time frame: 8 weeks

    HDL-cholesterol in mg/dL

  11. Metabolics Changes

    Time frame: 8 weeks

    triglycerides in mg/dL

  12. Metabolics Changes

    Time frame: 8 weeks

    Lipocalin-2 in mg/mL

  13. Metabolics Changes

    Time frame: 8 weeks

    Insulin in pmol/L

  14. Metabolics Changes

    Time frame: 8 weeks

    High sensitivity C-reactive protein in mg/L

  15. Metabolics Changes

    Time frame: 8 weeks

    adiponectin in microg/mL

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Registry information

Official study title

Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 7, 2017
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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