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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elva Perez-Luque, Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT03211754
First received: June 30, 2017
Last updated: July 6, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Obesity Dietary Supplement: walnuts and almonds

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects

Further study details as provided by Elva Perez-Luque, Universidad de Guanajuato:

Primary Outcome Measures:
  • Metabolics Changes [ Time Frame: 8 weeks ]
    fatty acids in percentage


Secondary Outcome Measures:
  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    Weight in kilograms

  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    height in meters

  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    waist circumference in centimeters

  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    hip circumference in centimeters

  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    fat mass in percentage

  • Significant decreases on all adiposity measures [ Time Frame: 8 weeks ]
    Weight and height will be combined to report BMI in kg/m2

  • Metabolics Changes [ Time Frame: 8 weeks ]
    Glucose in mg/dL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    total Cholesterol in mg/dL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    LDL-cholesterol in mg/dL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    HDL-cholesterol in mg/dL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    triglycerides in mg/dL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    Lipocalin-2 in mg/mL

  • Metabolics Changes [ Time Frame: 8 weeks ]
    Insulin in pmol/L

  • Metabolics Changes [ Time Frame: 8 weeks ]
    High sensitivity C-reactive protein in mg/L

  • Metabolics Changes [ Time Frame: 8 weeks ]
    adiponectin in microg/mL


Enrollment: 40
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese patients
Treatment for 8 weeks
Dietary Supplement: walnuts and almonds
The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Elva Perez-Luque, Profesor-Investigator, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03211754     History of Changes
Other Study ID Numbers: UGuanajuato
Study First Received: June 30, 2017
Last Updated: July 6, 2017

Keywords provided by Elva Perez-Luque, Universidad de Guanajuato:
Walnuts
almonds
adiponectin
lipocalin-2
obesity

Additional relevant MeSH terms:
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 11, 2017