ObesityNCT03211754
Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
A study testing walnuts and almonds in people with Obesity, run by Universidad de Guanajuato.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- walnuts and almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- obesity grade I
Who cannot join
- Subjects did not have evidence of chronic degenerative, infectious or neoplastic disease.
- Lack of adherence to the diet and consumption of walnuts and almonds
About this study
Official title: Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects
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.
- Conditions
- Obesity
- Being tested
- walnuts and almonds
- Keywords
- Walnuts, almonds, adiponectin, lipocalin-2, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnuts and almondsDietary supplement
The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Experimental | Treatment for 8 weeks Receives: Dietary Supplement: walnuts and almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolics Changes
fatty acids in percentage
Measured: 8 weeks
Secondary outcomes (15)
Significant decreases on all adiposity measures
Weight in kilograms
Measured: 8 weeks
Significant decreases on all adiposity measures
height in meters
Measured: 8 weeks
Significant decreases on all adiposity measures
waist circumference in centimeters
Measured: 8 weeks
Significant decreases on all adiposity measures
hip circumference in centimeters
Measured: 8 weeks
Significant decreases on all adiposity measures
fat mass in percentage
Measured: 8 weeks
Significant decreases on all adiposity measures
Weight and height will be combined to report BMI in kg/m2
Measured: 8 weeks
Metabolics Changes
Glucose in mg/dL
Measured: 8 weeks
Metabolics Changes
total Cholesterol in mg/dL
Measured: 8 weeks
Metabolics Changes
LDL-cholesterol in mg/dL
Measured: 8 weeks
Metabolics Changes
HDL-cholesterol in mg/dL
Measured: 8 weeks
Metabolics Changes
triglycerides in mg/dL
Measured: 8 weeks
Metabolics Changes
Lipocalin-2 in mg/mL
Measured: 8 weeks
Metabolics Changes
Insulin in pmol/L
Measured: 8 weeks
Metabolics Changes
High sensitivity C-reactive protein in mg/L
Measured: 8 weeks
Metabolics Changes
adiponectin in microg/mL
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startJan 2013
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elva Perez-Luque, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211754
- Sponsor's protocol ID
- UGuanajuato
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects
- ClinicalTrials.gov ID
- NCT03211754
- Acronym / sponsor ID
- UGuanajuato
- Conditions
- Obesity
- Keywords
- Walnuts, almonds, adiponectin, lipocalin-2, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | Experimental | Dietary Supplement: walnuts and almondsTreatment for 8 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- obesity grade I
Key exclusion criteria (2 listed)
- Subjects did not have evidence of chronic degenerative, infectious or neoplastic disease.
- Lack of adherence to the diet and consumption of walnuts and almonds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walnuts and almondsThe subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks | Dietary supplement | Obese patients |
Primary outcome
Metabolics Changes
Time frame: 8 weeks
fatty acids in percentage
15 secondary outcomes
Significant decreases on all adiposity measures
Time frame: 8 weeks
Significant decreases on all adiposity measures
Time frame: 8 weeks
Significant decreases on all adiposity measures
Time frame: 8 weeks
Significant decreases on all adiposity measures
Time frame: 8 weeks
Significant decreases on all adiposity measures
Time frame: 8 weeks
Significant decreases on all adiposity measures
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Metabolics Changes
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing walnuts and almonds in people with Obesity, run by Universidad de Guanajuato.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolics Changes (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.