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CompletedNCT03211754Updated Jul 7, 2017

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

An interventional study of walnuts and almonds in Obesity, sponsored by Universidad de Guanajuato. Completed. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-07.

Sponsored by Universidad de Guanajuato · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Walnuts
  • almonds
  • adiponectin
  • lipocalin-2
  • obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidad de Guanajuato is the lead sponsor of 35 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • obesity grade I

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Obese patients

    Treatment for 8 weeks

    Dietary Supplement: walnuts and almonds

Interventions

  • Dietary supplementwalnuts and almonds

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

06

What researchers measure

Primary outcomes

  1. Metabolics Changes

    fatty acids in percentage

    Time frame: 8 weeks

Secondary outcomes

  1. Significant decreases on all adiposity measures

    Weight in kilograms

    Time frame: 8 weeks

  2. Significant decreases on all adiposity measures

    height in meters

    Time frame: 8 weeks

  3. Significant decreases on all adiposity measures

    waist circumference in centimeters

    Time frame: 8 weeks

  4. Significant decreases on all adiposity measures

    hip circumference in centimeters

    Time frame: 8 weeks

  5. Significant decreases on all adiposity measures

    fat mass in percentage

    Time frame: 8 weeks

  6. Significant decreases on all adiposity measures

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

    Time frame: 8 weeks

  7. Metabolics Changes

    Glucose in mg/dL

    Time frame: 8 weeks

  8. Metabolics Changes

    total Cholesterol in mg/dL

    Time frame: 8 weeks

  9. Metabolics Changes

    LDL-cholesterol in mg/dL

    Time frame: 8 weeks

  10. Metabolics Changes

    HDL-cholesterol in mg/dL

    Time frame: 8 weeks

  11. Metabolics Changes

    triglycerides in mg/dL

    Time frame: 8 weeks

  12. Metabolics Changes

    Lipocalin-2 in mg/mL

    Time frame: 8 weeks

  13. Metabolics Changes

    Insulin in pmol/L

    Time frame: 8 weeks

  14. Metabolics Changes

    High sensitivity C-reactive protein in mg/L

    Time frame: 8 weeks

  15. Metabolics Changes

    adiponectin in microg/mL

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03211754
Lead sponsor
Universidad de Guanajuato
Responsible party
Elva Perez-Luque (Profesor-Investigator, Universidad de Guanajuato) — Principal investigator
First posted
Jul 7, 2017
Start date
Jan 2013
Primary completion
Sep 2013
Completion
Jan 2014
Last update
Jul 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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