Insulin ResistanceNCT07287514
Metabolic Effects of Linoleic Acid-Rich Oil Compared to a Blend Oil in Adults With Insulin Resistance
A study testing Linoleic Acid-Rich Oil and Blend Oil in people with Insulin Resistance and Metabolic Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Linoleic acid (LA), the predominant omega-6 polyunsaturated fatty acid in human diets, has been associated with improved lipid metabolism and insulin sensitivity compared with saturated fats. However, its role in metabolic health remains debated due to the limited number of well-controlled intervention studies. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Insulin Resistance, Metabolic Disease
- What is being tested?
- Linoleic Acid-Rich Oil and Blend Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChile
- Study dates
- 13 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 20 to 60 years.
- Insulin resistance (HOMA-IR > 2.6).
- At least one cardiometabolic risk factor: abdominal obesity (waist circumference > 90 cm in men or > 80 cm in women); low HDL-cholesterol (< 40 mg/dL in men or < 50 mg/dL in women); elevated LDL-cholesterol (> 70 / 100 / 130 mg/dL, according to estimated cardiovascular risk); or elevated blood pressure (≥ 130/85 mmHg).
Who cannot join
- Diabetes diagnosis.
- Severe psychiatric illness.
- Malabsorption disorders or previous bariatric surgery.
- Pregnancy or lactation.
- Previous clinical cardiovascular disease.
- Regular use of medications that could influence study outcomes, including:
Show all 11Show fewer
- lipid-lowering agents insulin sensitizers antihypertensive drugs anticoagulants antiretroviral therapy thyroid hormones oral corticosteroids immunosuppressants polyunsaturated fatty acid (PUFA) supplements.
- Fasting serum triglycerides ≥ 500 mg/dL or LDL-cholesterol ≥ 190 mg/dL.
- Body mass index (BMI) ≥ 35 kg/m².
- Very high blood pressure.
- Any additional condition that may limit adherence to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Centro de Investigaciones Clínicas UC (CICUC) - Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330024
Loni Berkowitz, PhD, lberkowi@uc.cl
About this study
Official title: Role of Linoleic Acid in Cardiometabolic Health Beyond Its Lipid-lowering Effects, and Its Dietary and Pathophysiological Implications
Linoleic acid (LA), the predominant omega-6 polyunsaturated fatty acid in human diets, has been associated with improved lipid metabolism and insulin sensitivity compared with saturated fats. However, its role in metabolic health remains debated due to the limited number of well-controlled intervention studies.
This randomized controlled trial aims to evaluate the metabolic effects of an LA-rich oil compared with a blended oil in adults with insulin resistance. Participants will be randomly assigned to receive either a daily supplement of LA-rich oil or a control blend oil for 8 weeks, while maintaining their usual diet and lifestyle. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include changes in fasting glucose, insulin, lipid profile, inflammatory and oxidative stress markers, and body composition.
The study is designed as a single-blind, parallel-group intervention conducted at the Pontifical Catholic University of Chile. The results are expected to clarify the effects of increased dietary linoleic acid intake on insulin sensitivity and metabolic risk factors, contributing to the ongoing debate about the role of omega-6 fatty acids in cardiometabolic health.
Read the detailed description
Background
Non-communicable diseases (NCDs) are among the leading causes of morbidity and mortality worldwide. A healthy diet may help reduce the risk of these conditions by modulating the availability of nutrients and metabolites. However, the underlying mechanisms are not fully understood and may even lead to misconceptions.
A common example is the widespread belief that a high intake of omega-6 polyunsaturated fatty acids (PUFAs) is harmful to health. Without strong scientific support, some have advocated limiting dietary linoleic acid (LA)-the predominant PUFA in human diets-under the assumption that it competes biochemically with omega-3 fatty acids, thereby reducing their beneficial effects. Nevertheless, meta-analyses of prospective cohort studies have shown that higher LA intake or circulating levels are associated with lower total and LDL cholesterol, reduced cardiovascular disease risk, and a lower incidence of type 2 diabetes. These findings highlight the need to reassess the biological effects of LA and its potential role in metabolic regulation. To support evidence-based dietary recommendations promoting LA intake, well-controlled intervention studies are needed to better understand its cardiometabolic effects.
Hypothesis
Elevated blood levels of linoleic acid (LA), in response to increased dietary intake, confer cardiometabolic benefits beyond lipid-lowering effects, improving insulin sensitivity and reducing cardiovascular risk in individuals with cardiometabolic risk conditions.
Objectives
The primary objective is to evaluate the effect of a short-term intervention with an LA-enriched oil on insulin sensitivity and glucose homeostasis in adults with insulin resistance.
Secondary objectives include assessing the impact of the intervention on lipid profile, circulating fatty acid composition, inflammatory status, hepatic enzymes, oxidative stress markers, and estimated cardiovascular risk in Chilean adults with insulin resistance and cardiometabolic risk conditions.
Experimental Design
This study is a randomized, single-blind, controlled, parallel-group clinical trial conducted at the Clinical Research Center (CICUC) of the Pontifical Catholic University of Chile. Eligible adults with insulin resistance will be randomly assigned in a 1:1 ratio to receive either a linoleic acid-rich oil or a blend oil for 8 weeks at a dose of 0.4 mL per kilogram of body weight per day. Fasting blood samples will be collected at baseline and at 8 weeks to assess insulin resistance (HOMA-IR), lipid profile, circulating fatty acid composition, inflammatory and oxidative stress markers (AOPP, oxidized LDL), and hepatic enzymes. Anthropometric and clinical parameters will also be recorded following standardized protocols.
- Conditions
- Insulin Resistance, Metabolic Disease
- Being tested
- Linoleic Acid-Rich Oil, Blend Oil
- Keywords
- linoleic acid, Insulin Resistance, omega-6 fatty acid
- Medical subject headings
- Insulin Resistance, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linoleic Acid-Rich OilDietary supplement
Participants in the experimental group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The oil is characterized by a high content of omega-6 polyunsaturated fatty acids, primarily linoleic acid (~60%).
To facilitate adherence and appropriate use, participants will receive a recipe booklet encouraging the use of the oil in cold or minimally cooked preparations, or as a topping over foods. They will be instructed to avoid prolonged heating and to store the oil protected from light and at room temperature.
The supplement will be provided in identical coded bottles to maintain single-blind conditions. Participants will be asked to maintain their usual diet and lifestyle throughout the intervention.
Blend OilDietary supplement
Participants in the control group will receive a daily supplement of a blend oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The blend was formulated to contain approximately equal proportions of saturated, monounsaturated, and polyunsaturated fatty acids, with less than half the linoleic acid content of the LA-rich oil.
Participants will receive a recipe booklet promoting the use of the oil in cold dishes or lightly cooked preparations, or as a dressing or drizzle over meals. They will also be instructed on proper storage away from heat and direct light.
The supplement will be supplied in identical coded bottles to ensure blinding. Participants will maintain their usual diet and lifestyle during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Linoleic Acid-Rich Oil | Experimental | Participants in this group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day for 8 weeks. Receives: Dietary Supplement: Linoleic Acid-Rich Oil |
| Blend Oil | Active comparator | Participants in this group will receive a daily supplement of a blend oil at 0.4 mL per kilogram of body weight per day for 8 weeks. Receives: Dietary Supplement: Blend Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance (HOMA-IR)
Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations. The primary outcome is the change in HOMA-IR from baseline to week 8 between the two study groups.
Measured: Baseline and 8 weeks after the start of the intervention.
Secondary outcomes (15)
Glycated hemoglobin (HbA1c)
HbA1c (%) will be measured to assess glucose homeostasis.
Measured: Baseline and week 8
Fasting glucose
Fasting glucose (mg/dL) will be measured to assess glucose homeostasis.
Measured: Baseline and week 8
Fasting insulin
Fasting insulin (µU/mL) will be measured to assess glucose homeostasis.
Measured: Baseline and week 8
Lipid profile
Plasma concentrations (mg/dL) of total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides will be determined using standard enzymatic assays.
Measured: Baseline and week 8
Liver enzymes
Hepatic function will be evaluated by measuring serum concentration (U/L) of alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), and gamma-glutamyl transferase (GGT).
Measured: Baseline and week 8
Body Weight
Body weight will be measured using a calibrated digital scale.
Measured: Baseline and week 8
Body mass index (BMI)
BMI will be calculated as weight (kg) divided by height squared (m²)
Measured: Baseline and week 8
Waist circumference
Waist circumference (cm) will be measured with a non-stretchable tape at the midpoint between the iliac crest and the lowest rib
Measured: Baseline and week 8
Inflammatory markers
Serum levels of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) will be measured to assess systemic inflammation.
Measured: Baseline and week 8
Oxidative stress markers
Advanced oxidation protein products (AOPP) and oxidized LDL (oxLDL) will be measured in plasma as indicators of oxidative stress.
Measured: Baseline and week 8
Change in plasma fatty acid profile
The plasma fatty acid composition will be determined from fasting samples by gas chromatography. Relative and absolute concentrations of major fatty acids, including linoleic acid, arachidonic acid, and docosahexaenoic acid, will be quantified to assess changes in circulating lipid composition and adherence to the assigned oil intervention.
Measured: Baseline and week 8
24-hour dietary recall
Two non-consecutive 24-hour food recalls will be applied by trained dietitians at baseline and during the last week of the intervention to assess nutrient intake. Nutrient intake will be analyzed using ESHA's Food Processor® Nutrition Analysis software.
Measured: Baseline and week 8
Diet quality (Chilean MDI)
Self-reported diet quality will be assessed using the Chilean Mediterranean Dietary Index (Chilean-MDI) questionnaire. The scale ranges from 0 to 14 points, where higher scores indicate greater adherence to the Mediterranean dietary pattern, reflecting better diet quality. A score of 0 represents no adherence, and 14 represents maximum adherence.
Measured: Baseline and week 8
Sleep quality (PSQI)
Self-reported sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline and post-intervention. The PSQI assesses subjective sleep quality across seven components, yielding a global score from 0 to 21. Higher scores indicate poorer sleep quality, with values >5 typically reflecting clinically relevant sleep disturbances.
Measured: Baseline and week 8
Physical activity (GPAQ)
Self-reported physical activity assessed using the Global Physical Activity Questionnaire (GPAQ) at baseline and post-intervention. GPAQ provides total physical activity expressed in MET-minutes/week, typically ranging from 0 to >10,000 MET-min/week. Higher values indicate greater overall physical activity, while lower values reflect insufficient activity.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start13 May 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: 1. an intervention group receiving a linoleic acid-rich oil, or 2. a control group receiving a blended oil. The study follows a single-blind, parallel-group design lasting 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loni Berkowitz Fiebich, Pontificia Universidad Catolica de Chile
- Investigators
- Loni Berkowitz, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287514
- Sponsor's protocol ID
- 230330018
- Other IDs
- 11240454
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only aggregated results will be made available through scientific publications and presentations.
Publications
Berkowitz L, Echeverria G, Salazar C, Faundez C, Coe CL, Ryff C, Rigotti A. Lipidomic Signature of Healthy Diet Adherence and Its Association with Cardiometabolic Risk in American Adults. Nutrients. 2024 Nov 22;16(23):3995. doi: 10.3390/nu16233995.
PubMed 39683389Berkowitz L, Razquin C, Salazar C, Biancardi F, Estruch R, Ros E, Fito M, Corella D, Coe CL, Ryff CD, Ruiz-Canela M, Salas-Salvado J, Wang D, Hu FB, Deik A, Martinez-Gonzalez MA, Rigotti A. Sphingolipid profiling as a biomarker of type 2 diabetes risk: evidence from the MIDUS and PREDIMED studies. Cardiovasc Diabetol. 2024 Dec 18;23(1):446. doi: 10.1186/s12933-024-02505-7.
PubMed 39695759Berkowitz L, Mateo C, Salazar C, Samith B, Sara D, Pinto V, Martinez X, Calzada M, von Schultzendorff A, Pedrals N, Bitran M, Echeverria G, Ruini C, Ryff C, Rigotti A. Healthy Eating as Potential Mediator of Inverse Association between Purpose in Life and Waist Circumference: Emerging Evidence from US and Chilean Cohorts. Int J Environ Res Public Health. 2023 Nov 23;20(23):7099. doi: 10.3390/ijerph20237099.
PubMed 38063529Calderon M, Plaza G, Gomez M, Samith B, Pinto V, Martinez X, Sara D, Echeverria G, Calzada M, Berkowitz L, von Schultzendorff A, Pedrals N, Bitran M, Rigotti AG. [Limitations and opportunities for the appropriation of the Mediterranean diet in Chilean adults with diagnostic elements of metabolic syndrome]. Nutr Hosp. 2024 Feb 15;41(1):86-95. doi: 10.20960/nh.04652. Spanish.
PubMed 38047416Echeverria G, Samith B, von Schultzendorf A, Pinto V, Martinez X, Sara D, Calzada M, Pacheco J, Plaza G, Scott F, Romero J, Mateo C, Julio MV, Utreras-Mendoza Y, Binder MV, Gutierrez F, Riquelme ME, Cuevas M, Willatt R, Sanchez O, Keilendt A, Butron P, Jarufe A, Huete I, Tobar J, Martin S, Alfaro V, Olivos M, Pedrals N, Bitran M, Avalos I, Ruini C, Ryff C, Perez D, Berkowitz L, Rigotti A. Mediterranean diet and psychological well-being intervention to reverse metabolic syndrome in Chile (CHILEMED trial). Contemp Clin Trials Commun. 2023 Jun 26;35:101167. doi: 10.1016/j.conctc.2023.101167. eCollection 2023 Oct.
PubMed 37538196
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Linoleic Acid in Cardiometabolic Health Beyond Its Lipid-lowering Effects, and Its Dietary and Pathophysiological Implications
- ClinicalTrials.gov ID
- NCT07287514
- Acronym / sponsor ID
- 230330018
- Conditions
- Insulin Resistance, Metabolic Disease
- Keywords
- linoleic acid, Insulin Resistance, omega-6 fatty acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
Linoleic acid (LA), the predominant omega-6 polyunsaturated fatty acid in human diets, has been associated with improved lipid metabolism and insulin sensitivity compared with saturated fats. However, its role in metabolic health remains debated due to the limited number of well-controlled intervention studies.
This randomized controlled trial aims to evaluate the metabolic effects of an LA-rich oil compared with a blended oil in adults with insulin resistance. Participants will be randomly assigned to receive either a daily supplement of LA-rich oil or a control blend oil for 8 weeks, while maintaining their usual diet and lifestyle. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include changes in fasting glucose, insulin, lipid profile, inflammatory and oxidative stress markers, and body composition.
The study is designed as a single-blind, parallel-group intervention conducted at the Pontifical Catholic University of Chile. The results are expected to clarify the effects of increased dietary linoleic acid intake on insulin sensitivity and metabolic risk factors, contributing to the ongoing debate about the role of omega-6 fatty acids in cardiometabolic health.
Detailed description
Background
Non-communicable diseases (NCDs) are among the leading causes of morbidity and mortality worldwide. A healthy diet may help reduce the risk of these conditions by modulating the availability of nutrients and metabolites. However, the underlying mechanisms are not fully understood and may even lead to misconceptions.
A common example is the widespread belief that a high intake of omega-6 polyunsaturated fatty acids (PUFAs) is harmful to health. Without strong scientific support, some have advocated limiting dietary linoleic acid (LA)-the predominant PUFA in human diets-under the assumption that it competes biochemically with omega-3 fatty acids, thereby reducing their beneficial effects. Nevertheless, meta-analyses of prospective cohort studies have shown that higher LA intake or circulating levels are associated with lower total and LDL cholesterol, reduced cardiovascular disease risk, and a lower incidence of type 2 diabetes. These findings highlight the need to reassess the biological effects of LA and its potential role in metabolic regulation. To support evidence-based dietary recommendations promoting LA intake, well-controlled intervention studies are needed to better understand its cardiometabolic effects.
Hypothesis
Elevated blood levels of linoleic acid (LA), in response to increased dietary intake, confer cardiometabolic benefits beyond lipid-lowering effects, improving insulin sensitivity and reducing cardiovascular risk in individuals with cardiometabolic risk conditions.
Objectives
The primary objective is to evaluate the effect of a short-term intervention with an LA-enriched oil on insulin sensitivity and glucose homeostasis in adults with insulin resistance.
Secondary objectives include assessing the impact of the intervention on lipid profile, circulating fatty acid composition, inflammatory status, hepatic enzymes, oxidative stress markers, and estimated cardiovascular risk in Chilean adults with insulin resistance and cardiometabolic risk conditions.
Experimental Design
This study is a randomized, single-blind, controlled, parallel-group clinical trial conducted at the Clinical Research Center (CICUC) of the Pontifical Catholic University of Chile. Eligible adults with insulin resistance will be randomly assigned in a 1:1 ratio to receive either a linoleic acid-rich oil or a blend oil for 8 weeks at a dose of 0.4 mL per kilogram of body weight per day. Fasting blood samples will be collected at baseline and at 8 weeks to assess insulin resistance (HOMA-IR), lipid profile, circulating fatty acid composition, inflammatory and oxidative stress markers (AOPP, oxidized LDL), and hepatic enzymes. Anthropometric and clinical parameters will also be recorded following standardized protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: 1. an intervention group receiving a linoleic acid-rich oil, or 2. a control group receiving a blended oil. The study follows a single-blind, parallel-group design lasting 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Linoleic Acid-Rich Oil | Experimental | Dietary Supplement: Linoleic Acid-Rich OilParticipants in this group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day for 8 weeks. |
| Blend Oil | Active comparator | Dietary Supplement: Blend OilParticipants in this group will receive a daily supplement of a blend oil at 0.4 mL per kilogram of body weight per day for 8 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women aged 20 to 60 years.
- Insulin resistance (HOMA-IR > 2.6).
- At least one cardiometabolic risk factor: abdominal obesity (waist circumference > 90 cm in men or > 80 cm in women); low HDL-cholesterol (< 40 mg/dL in men or < 50 mg/dL in women); elevated LDL-cholesterol (> 70 / 100 / 130 mg/dL, according to estimated cardiovascular risk); or elevated blood pressure (≥ 130/85 mmHg).
Key exclusion criteria (11 listed)
- Diabetes diagnosis.
- Severe psychiatric illness.
- Malabsorption disorders or previous bariatric surgery.
- Pregnancy or lactation.
- Previous clinical cardiovascular disease.
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 |
|---|---|---|
| Linoleic Acid-Rich OilParticipants in the experimental group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The oil is characterized by a high content of omega-6 polyunsaturated fatty acids, primarily linoleic acid (~60%). To facilitate adherence and appropriate use, participants will receive a recipe booklet encouraging the use of the oil in cold or minimally cooked preparations, or as a topping over foods. They will be instructed to avoid prolonged heating and to store the oil protected from light and at room temperature. The supplement will be provided in identical coded bottles to maintain single-blind conditions. Participants will be asked to maintain their usual diet and lifestyle throughout the intervention. | Dietary supplement | Linoleic Acid-Rich Oil |
| Blend OilParticipants in the control group will receive a daily supplement of a blend oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The blend was formulated to contain approximately equal proportions of saturated, monounsaturated, and polyunsaturated fatty acids, with less than half the linoleic acid content of the LA-rich oil. Participants will receive a recipe booklet promoting the use of the oil in cold dishes or lightly cooked preparations, or as a dressing or drizzle over meals. They will also be instructed on proper storage away from heat and direct light. The supplement will be supplied in identical coded bottles to ensure blinding. Participants will maintain their usual diet and lifestyle during the intervention. | Dietary supplement | Blend Oil |
Primary outcome
Change in insulin resistance (HOMA-IR)
Time frame: Baseline and 8 weeks after the start of the intervention.
Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations. The primary outcome is the change in HOMA-IR from baseline to week 8 between the two study groups.
15 secondary outcomes
Glycated hemoglobin (HbA1c)
Time frame: Baseline and week 8
Fasting glucose
Time frame: Baseline and week 8
Fasting insulin
Time frame: Baseline and week 8
Lipid profile
Time frame: Baseline and week 8
Liver enzymes
Time frame: Baseline and week 8
Body Weight
Time frame: Baseline and week 8
Body mass index (BMI)
Time frame: Baseline and week 8
Waist circumference
Time frame: Baseline and week 8
Inflammatory markers
Time frame: Baseline and week 8
Oxidative stress markers
Time frame: Baseline and week 8
Change in plasma fatty acid profile
Time frame: Baseline and week 8
24-hour dietary recall
Time frame: Baseline and week 8
Diet quality (Chilean MDI)
Time frame: Baseline and week 8
Sleep quality (PSQI)
Time frame: Baseline and week 8
Physical activity (GPAQ)
Time frame: Baseline and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 39683389Berkowitz L, Echeverria G, Salazar C, Faundez C, Coe CL, Ryff C, Rigotti A. Lipidomic Signature of Healthy Diet Adherence and Its Association with Cardiometabolic Risk in American Adults. Nutrients. 2024 Nov 22;16(23):3995. doi: 10.3390/nu16233995.
- Background: PubMed 39695759Berkowitz L, Razquin C, Salazar C, Biancardi F, Estruch R, Ros E, Fito M, Corella D, Coe CL, Ryff CD, Ruiz-Canela M, Salas-Salvado J, Wang D, Hu FB, Deik A, Martinez-Gonzalez MA, Rigotti A. Sphingolipid profiling as a biomarker of type 2 diabetes risk: evidence from the MIDUS and PREDIMED studies. Cardiovasc Diabetol. 2024 Dec 18;23(1):446. doi: 10.1186/s12933-024-02505-7.
- Background: PubMed 38063529Berkowitz L, Mateo C, Salazar C, Samith B, Sara D, Pinto V, Martinez X, Calzada M, von Schultzendorff A, Pedrals N, Bitran M, Echeverria G, Ruini C, Ryff C, Rigotti A. Healthy Eating as Potential Mediator of Inverse Association between Purpose in Life and Waist Circumference: Emerging Evidence from US and Chilean Cohorts. Int J Environ Res Public Health. 2023 Nov 23;20(23):7099. doi: 10.3390/ijerph20237099.
- Background: PubMed 38047416Calderon M, Plaza G, Gomez M, Samith B, Pinto V, Martinez X, Sara D, Echeverria G, Calzada M, Berkowitz L, von Schultzendorff A, Pedrals N, Bitran M, Rigotti AG. [Limitations and opportunities for the appropriation of the Mediterranean diet in Chilean adults with diagnostic elements of metabolic syndrome]. Nutr Hosp. 2024 Feb 15;41(1):86-95. doi: 10.20960/nh.04652. Spanish.
- Background: PubMed 37538196Echeverria G, Samith B, von Schultzendorf A, Pinto V, Martinez X, Sara D, Calzada M, Pacheco J, Plaza G, Scott F, Romero J, Mateo C, Julio MV, Utreras-Mendoza Y, Binder MV, Gutierrez F, Riquelme ME, Cuevas M, Willatt R, Sanchez O, Keilendt A, Butron P, Jarufe A, Huete I, Tobar J, Martin S, Alfaro V, Olivos M, Pedrals N, Bitran M, Avalos I, Ruini C, Ryff C, Perez D, Berkowitz L, Rigotti A. Mediterranean diet and psychological well-being intervention to reverse metabolic syndrome in Chile (CHILEMED trial). Contemp Clin Trials Commun. 2023 Jun 26;35:101167. doi: 10.1016/j.conctc.2023.101167. eCollection 2023 Oct.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only aggregated results will be made available through scientific publications and presentations.
Related trials for Insulin Resistance
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
Loni Berkowitz, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linoleic Acid-Rich Oil and Blend Oil in people with Insulin Resistance and Metabolic Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loni Berkowitz, PhD (23543862 ext. +56, lberkowi@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin resistance (HOMA-IR) (time frame: Baseline and 8 weeks after the start of the intervention.). 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 NCT07287514, which also lists 5 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 17 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.