ObesityNCT04901052
Effects of n-3 Intake on Lipid Profile, Biochemical and Inflammatory Markers in Subjects With Obesity
A study testing n-3 supplementation group in people with Obesity, run by University of Guadalajara at 2 sites in Mexico.
Trial summary
Obesity is a chronic disease characterized by the excessive accumulation of adipose tissue that is harmful to health. Dietary habits modification through a caloric restriction, macronutrient distribution including linoleic and linolenic (n-6:n-3) polyunsaturated fatty acids (PUFAs) ratio, has been suggested for… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- n-3 supplementation group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesMexico
- Study dates
- 10 Jan 2018to 15 Mar 2019
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes
- Mestizo from West Mexico
- Age between 30 to 50 years of age
- Sign the Informed Consent
- Diagnostic of Obesity type I and II according to BMI (30 - 40kg / m2)
- Waist circumference (WC) women ≥80cm, men ≥90cm
- Sedentary lifestyle ˂ 150 minutes per week
Who cannot join
- Pregnant or breastfeeding women
- Diabetes disease
- Cardiovascular disease
- Any type of cancer disease Tobacco and alcohol (consumption ≥ 40 g of alcohol per day for men and ≥ 20 g for women)
- Participants that consume n-3 supplements, anti-inflammatory medications, or some type of lipid-lowering drugs in the past year
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
University of Guadalajara
Guadalajara, Jaliscco, 44280
Erika Martínez-López
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of a Diet Supplemented With Omega-3 on Biochemical Variables, Cytokine Concentration and Fatty Acid Profile in Subjects With Obesity
Obesity is a chronic disease characterized by the excessive accumulation of adipose tissue that is harmful to health. Dietary habits modification through a caloric restriction, macronutrient distribution including linoleic and linolenic (n-6:n-3) polyunsaturated fatty acids (PUFAs) ratio, has been suggested for obesity management. It has been proposed that the optimal n-6: n-3 ratio should be between 1:1 and 5:1 to maintain a healthy balance. Purpose: Compare the effect of a diet n6:n3 ratio of polyunsaturated fatty acids with a group supplemented with n-3 PUFA on lipid profile in erythrocyte membrane, biochemical and inflammatory markers in subjects with obesity.
Methods: 58 subjects were randomly divided into two groups: fish oil group and the placebo group. Anthropometric and biochemical data were evaluated, cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. The fatty acid profile quantification in the erythrocyte membrane was carried out by gas chromatography. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.
Read the detailed description
A randomized clinical trial was conducted at the Institute of Translational Nutrigenetics and Nutrigenomics of the University of Guadalajara. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 19 participants in each study group was required. However, 58 obese individuals who met the selection criteria were randomized in n-3 group or placebo group.
Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes.
The nutritional intervention consisted in 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study. Fish oil group besides the diet was supplemented with omega 3, the dosage was 2 capsules per day, containing 1.5 g of total omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch, and a toxicity analysis was performed to verify the safety or the placebo group (2 capsules per day made from sunflower oil).
This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (Registration number CI-01219) and was carried out according to the Declaration of Helsinki (2013) and all the participants signed a written consent-informed.
- Conditions
- Obesity
- Being tested
- n-3 supplementation group, Placebo group
- Keywords
- Dietary Supplementations, Anti-Inflammatory Agent
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 supplementation groupDietary supplement
n-3 supplementation group (1.5g of omega 3)
Placebo groupDietary supplement
Also called Placebo group (sunflower oil)
Placebo group (sunflower oil)
| Study group | Role | What they receive |
|---|---|---|
| n-3 supplementation group | Experimental | The nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus Omega 3 supplementation, the dosage was 2 capsules per day, containing 1.5 g of omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch. Receives: Dietary Supplement: n-3 supplementation group |
| Placebo group | Placebo comparator | The nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus placebo capsules (2 capsules per day made from sunflower oil) Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fatty acid profile quantification
All the samples was performed in a Gas Chromatograph (GC) Agilent Technologies, 6850 network system coupled to an injector (Agilent Technologies, 7083 Series) with a column for fatty acids (Durabond, DB-23). flame ionization detector with helium as gas carrier (0.7 cm3 min-1) and a temperature ramp (110 °C - 220 °C).
Measured: Mean change from baseline (0 Month) to end of treatment at 4th Month
Pro-inflammatory and Anti-inflammatory Cytokines profile in serum
The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.
The 17 cytokine include: IL1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17A, G-CSF, GM-CSF, INF-γ, MCP-1, MIP1α, TNFα. Units of measure in pg/ml.
Measured: Mean change from baseline (0 Month) to end of treatment at 4th Month
Secondary outcomes (10)
Changes in Weight
The weight was measured in kilograms on InBody 370
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Body Mass Index (BMI)
Weight and height were be combined to report BMI in kg/m^2
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Waist Circumference
Waist circumference was measured at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Fat Mass
The Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Serum Glucose
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Serum Insulin
Were determined through Insulin Model ELISA kit following the supplier's instructions.
Measured: At the baseline (0 Month) and the 4th month
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.
Measured: At the baseline (0 Month) and the 4th month
Changes in Total Cholesterol
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in High-density lipoprotein (c-HDL)
It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Low-density lipoprotein (c-LDL)
It was calculated using Friedewald formula
Measured: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start10 Jan 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Parallel with placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario de Ciencias de la Salud, Mexico, Hospital Civil de Guadalajara
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
- Investigators
- Erika Martinez-Lopez, PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901052
- Sponsor's protocol ID
- CI-01219
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
Publications
Albracht-Schulte K, Kalupahana NS, Ramalingam L, Wang S, Rahman SM, Robert-McComb J, Moustaid-Moussa N. Omega-3 fatty acids in obesity and metabolic syndrome: a mechanistic update. J Nutr Biochem. 2018 Aug;58:1-16. doi: 10.1016/j.jnutbio.2018.02.012. Epub 2018 Feb 27.
PubMed 29621669Torres-Castillo N, Silva-Gomez JA, Campos-Perez W, Barron-Cabrera E, Hernandez-Canaveral I, Garcia-Cazarin M, Marquez-Sandoval Y, Gonzalez-Becerra K, Barron-Gallardo C, Martinez-Lopez E. High Dietary omega-6:omega-3 PUFA Ratio Is Positively Associated with Excessive Adiposity and Waist Circumference. Obes Facts. 2018;11(4):344-353. doi: 10.1159/000492116. Epub 2018 Aug 10.
PubMed 30092569Vannice G, Rasmussen H. Position of the academy of nutrition and dietetics: dietary fatty acids for healthy adults. J Acad Nutr Diet. 2014 Jan;114(1):136-53. doi: 10.1016/j.jand.2013.11.001.
PubMed 24342605Bruun JM, Lihn AS, Madan AK, Pedersen SB, Schiott KM, Fain JN, Richelsen B. Higher production of IL-8 in visceral vs. subcutaneous adipose tissue. Implication of nonadipose cells in adipose tissue. Am J Physiol Endocrinol Metab. 2004 Jan;286(1):E8-13. doi: 10.1152/ajpendo.00269.2003. Epub 2003 Sep 16.
PubMed 13129857Oh DY, Talukdar S, Bae EJ, Imamura T, Morinaga H, Fan W, Li P, Lu WJ, Watkins SM, Olefsky JM. GPR120 is an omega-3 fatty acid receptor mediating potent anti-inflammatory and insulin-sensitizing effects. Cell. 2010 Sep 3;142(5):687-98. doi: 10.1016/j.cell.2010.07.041.
PubMed 20813258Gurzell EA, Wiesinger JA, Morkam C, Hemmrich S, Harris WS, Fenton JI. Is the omega-3 index a valid marker of intestinal membrane phospholipid EPA+DHA content? Prostaglandins Leukot Essent Fatty Acids. 2014 Sep;91(3):87-96. doi: 10.1016/j.plefa.2014.04.001. Epub 2014 Apr 24.
PubMed 24913088
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Diet Supplemented With Omega-3 on Biochemical Variables, Cytokine Concentration and Fatty Acid Profile in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT04901052
- Acronym / sponsor ID
- CI-01219
- Conditions
- Obesity
- Keywords
- Dietary Supplementations, Anti-Inflammatory Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Centro Universitario de Ciencias de la Salud, Mexico, Hospital Civil de Guadalajara
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 25 May 2021 (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.
Obesity is a chronic disease characterized by the excessive accumulation of adipose tissue that is harmful to health. Dietary habits modification through a caloric restriction, macronutrient distribution including linoleic and linolenic (n-6:n-3) polyunsaturated fatty acids (PUFAs) ratio, has been suggested for obesity management. It has been proposed that the optimal n-6: n-3 ratio should be between 1:1 and 5:1 to maintain a healthy balance. Purpose: Compare the effect of a diet n6:n3 ratio of polyunsaturated fatty acids with a group supplemented with n-3 PUFA on lipid profile in erythrocyte membrane, biochemical and inflammatory markers in subjects with obesity.
Methods: 58 subjects were randomly divided into two groups: fish oil group and the placebo group. Anthropometric and biochemical data were evaluated, cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. The fatty acid profile quantification in the erythrocyte membrane was carried out by gas chromatography. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.
Detailed description
A randomized clinical trial was conducted at the Institute of Translational Nutrigenetics and Nutrigenomics of the University of Guadalajara. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 19 participants in each study group was required. However, 58 obese individuals who met the selection criteria were randomized in n-3 group or placebo group.
Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes.
The nutritional intervention consisted in 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study. Fish oil group besides the diet was supplemented with omega 3, the dosage was 2 capsules per day, containing 1.5 g of total omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch, and a toxicity analysis was performed to verify the safety or the placebo group (2 capsules per day made from sunflower oil).
This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (Registration number CI-01219) and was carried out according to the Declaration of Helsinki (2013) and all the participants signed a written consent-informed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized Parallel with placebo
| Arm | Type | Receives |
|---|---|---|
| n-3 supplementation group | Experimental | Dietary Supplement: n-3 supplementation groupThe nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus Omega 3 supplementation, the dosage was 2 capsules per day, containing 1.5 g of omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThe nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus placebo capsules (2 capsules per day made from sunflower oil) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects of both sexes
- Mestizo from West Mexico
- Age between 30 to 50 years of age
- Sign the Informed Consent
- Diagnostic of Obesity type I and II according to BMI (30 - 40kg / m2)
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Diabetes disease
- Cardiovascular disease
- Any type of cancer disease Tobacco and alcohol (consumption ≥ 40 g of alcohol per day for men and ≥ 20 g for women)
- Participants that consume n-3 supplements, anti-inflammatory medications, or some type of lipid-lowering drugs in the past year
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 |
|---|---|---|
| n-3 supplementation groupn-3 supplementation group (1.5g of omega 3) | Dietary supplement | n-3 supplementation group |
| Placebo groupAlso: Placebo group (sunflower oil)Placebo group (sunflower oil) | Dietary supplement | Placebo group |
Primary outcome
The fatty acid profile quantification
Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month
All the samples was performed in a Gas Chromatograph (GC) Agilent Technologies, 6850 network system coupled to an injector (Agilent Technologies, 7083 Series) with a column for fatty acids (Durabond, DB-23). flame ionization detector with helium as gas carrier (0.7 cm3 min-1) and a temperature ramp (110 °C - 220 °C).
Pro-inflammatory and Anti-inflammatory Cytokines profile in serum
Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month
The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer. The 17 cytokine include: IL1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17A, G-CSF, GM-CSF, INF-γ, MCP-1, MIP1α, TNFα. Units of measure in pg/ml.
10 secondary outcomes
Changes in Weight
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Body Mass Index (BMI)
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Waist Circumference
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Changes in Fat Mass
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Serum Glucose
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Serum Insulin
Time frame: At the baseline (0 Month) and the 4th month
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Time frame: At the baseline (0 Month) and the 4th month
Changes in Total Cholesterol
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in High-density lipoprotein (c-HDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Changes in Low-density lipoprotein (c-LDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
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 15 Nov 2024.
- Results publication: PubMed 29621669Albracht-Schulte K, Kalupahana NS, Ramalingam L, Wang S, Rahman SM, Robert-McComb J, Moustaid-Moussa N. Omega-3 fatty acids in obesity and metabolic syndrome: a mechanistic update. J Nutr Biochem. 2018 Aug;58:1-16. doi: 10.1016/j.jnutbio.2018.02.012. Epub 2018 Feb 27.
- Results publication: PubMed 30092569Torres-Castillo N, Silva-Gomez JA, Campos-Perez W, Barron-Cabrera E, Hernandez-Canaveral I, Garcia-Cazarin M, Marquez-Sandoval Y, Gonzalez-Becerra K, Barron-Gallardo C, Martinez-Lopez E. High Dietary omega-6:omega-3 PUFA Ratio Is Positively Associated with Excessive Adiposity and Waist Circumference. Obes Facts. 2018;11(4):344-353. doi: 10.1159/000492116. Epub 2018 Aug 10.
- Results publication: PubMed 24342605Vannice G, Rasmussen H. Position of the academy of nutrition and dietetics: dietary fatty acids for healthy adults. J Acad Nutr Diet. 2014 Jan;114(1):136-53. doi: 10.1016/j.jand.2013.11.001.
- Results publication: PubMed 13129857Bruun JM, Lihn AS, Madan AK, Pedersen SB, Schiott KM, Fain JN, Richelsen B. Higher production of IL-8 in visceral vs. subcutaneous adipose tissue. Implication of nonadipose cells in adipose tissue. Am J Physiol Endocrinol Metab. 2004 Jan;286(1):E8-13. doi: 10.1152/ajpendo.00269.2003. Epub 2003 Sep 16.
- Results publication: PubMed 20813258Oh DY, Talukdar S, Bae EJ, Imamura T, Morinaga H, Fan W, Li P, Lu WJ, Watkins SM, Olefsky JM. GPR120 is an omega-3 fatty acid receptor mediating potent anti-inflammatory and insulin-sensitizing effects. Cell. 2010 Sep 3;142(5):687-98. doi: 10.1016/j.cell.2010.07.041.
- Results publication: PubMed 24913088Gurzell EA, Wiesinger JA, Morkam C, Hemmrich S, Harris WS, Fenton JI. Is the omega-3 index a valid marker of intestinal membrane phospholipid EPA+DHA content? Prostaglandins Leukot Essent Fatty Acids. 2014 Sep;91(3):87-96. doi: 10.1016/j.plefa.2014.04.001. Epub 2014 Apr 24.
- World Health OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
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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.
Erika Martinez-Lopez, PhD study director
University of Guadalajara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 supplementation group in people with Obesity, run by University of Guadalajara at 2 sites in Mexico.
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 7 inclusion and 5 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The fatty acid profile quantification (time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901052, which also lists 6 linked publications.
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 15 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.