search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walnuts and almonds
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Walnuts, almonds, adiponectin, lipocalin-2, obesity

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Obese patients

    Arm Description

    Treatment for 8 weeks

    Outcomes

    Primary Outcome Measures

    Metabolics Changes
    fatty acids in percentage

    Secondary Outcome Measures

    Significant decreases on all adiposity measures
    Weight in kilograms
    Significant decreases on all adiposity measures
    height in meters
    Significant decreases on all adiposity measures
    waist circumference in centimeters
    Significant decreases on all adiposity measures
    hip circumference in centimeters
    Significant decreases on all adiposity measures
    fat mass in percentage
    Significant decreases on all adiposity measures
    Weight and height will be combined to report BMI in kg/m2
    Metabolics Changes
    Glucose in mg/dL
    Metabolics Changes
    total Cholesterol in mg/dL
    Metabolics Changes
    LDL-cholesterol in mg/dL
    Metabolics Changes
    HDL-cholesterol in mg/dL
    Metabolics Changes
    triglycerides in mg/dL
    Metabolics Changes
    Lipocalin-2 in mg/mL
    Metabolics Changes
    Insulin in pmol/L
    Metabolics Changes
    High sensitivity C-reactive protein in mg/L
    Metabolics Changes
    adiponectin in microg/mL

    Full Information

    First Posted
    June 30, 2017
    Last Updated
    July 6, 2017
    Sponsor
    Universidad de Guanajuato
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03211754
    Brief Title
    Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
    Official Title
    Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Guanajuato

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Walnuts, almonds, adiponectin, lipocalin-2, obesity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obese patients
    Arm Type
    Experimental
    Arm Description
    Treatment for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    walnuts and almonds
    Intervention Description
    The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks
    Primary Outcome Measure Information:
    Title
    Metabolics Changes
    Description
    fatty acids in percentage
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Significant decreases on all adiposity measures
    Description
    Weight in kilograms
    Time Frame
    8 weeks
    Title
    Significant decreases on all adiposity measures
    Description
    height in meters
    Time Frame
    8 weeks
    Title
    Significant decreases on all adiposity measures
    Description
    waist circumference in centimeters
    Time Frame
    8 weeks
    Title
    Significant decreases on all adiposity measures
    Description
    hip circumference in centimeters
    Time Frame
    8 weeks
    Title
    Significant decreases on all adiposity measures
    Description
    fat mass in percentage
    Time Frame
    8 weeks
    Title
    Significant decreases on all adiposity measures
    Description
    Weight and height will be combined to report BMI in kg/m2
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    Glucose in mg/dL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    total Cholesterol in mg/dL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    LDL-cholesterol in mg/dL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    HDL-cholesterol in mg/dL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    triglycerides in mg/dL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    Lipocalin-2 in mg/mL
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    Insulin in pmol/L
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    High sensitivity C-reactive protein in mg/L
    Time Frame
    8 weeks
    Title
    Metabolics Changes
    Description
    adiponectin in microg/mL
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs