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Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents

The Impact of Using omega3 Long-chain Polyunsaturated Fatty Acids in Weight Loss and Insulin Resistance in Obese Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01456221
Acronym
O3WLIRADOL
Enrollment
366
Registered
2011-10-20
Start date
2012-07-31
Completion date
2017-01-31
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Obesity, Insulin resistance, Omega3 long chain polyunsaturated fatty acids

Brief summary

The purpose of this study is to evaluate if a supplement containing omega-3 long chain polyunsaturated fatty acids for three months reduce obesity and insulin resistance to obese adolescents if administered together with a hypocaloric diet.

Detailed description

Background: In 2006, the prevalence of overweight and obesity combined in scholar and adolescents in Mexico was 26% and 31% respectively, which represents more than double of that reported in year 2000. Together with such increments in the obesity rates, it was observed similar increases in the incidence of other metabolic conditions such as insulin resistance (IR). In a very simplistic manner, it seems that the link between obesity and IR is a chronic inflammatory status because the adipose tissue-derived inflammatory molecules interfere with the uptake of fatty acids and glucose in peripheral tissues. On the other hand, it is accepted that the long-chain polyunsaturated fatty acids (LCPUFA) omega-3 exhibit anti-inflammatory properties. In addition, it has been also demonstrated the beneficial effect exerted by such fatty acids on insulin sensitivity, and in stabilizing the weight lost achieved with hypocaloric diets. At present, the prevalence of overweight and obesity combined are in the range of 41-43% in the adolescent population that attend the four areas of influence of the Mexican Institute of Social Security (IMSS) in Mexico City. Interventions addressed to improve the nutritional status of these groups of age are expected to impact the risk for IR and its associated co-morbidities. Objective: To evaluate the impact of supplementation with LCPUFA omega-3, together with a dietary strategy, on obesity and insulin resistance in a sample of obese adolescents attended in the IMSS. Methods: In a randomized clinical design, 300 obese individuals, 12-18 years old, will be selected. At selection, individuals will be randomly assigned to receive daily a capsule with 1.1 g LCPUFA omega-3 during three mo together with a hypocaloric diet which follows the World Health Organization (WHO) recommendations (D+O3), or to receive daily a capsule with 1.0 g sunflower oil and a similar diet (P+D). After randomization, dietary information (24h-recall and FFQ), anthropometric measurements, and peripheral blood samples, will be obtained. Blood samples will be used to determine fasting plasma glucose and insulin, and erythrocytes fatty acid profile; such determinations will be repeated at three and six mo of follow-up. Anthropometry and 24 h-recalls will be repeated monthly. For follow-up, studied subjects will be evaluated monthly to deliver capsules and to check for dietary adherence. Treatments will be administered during three months and the follow-up will continue throughout six months. At the end of the follow-up it is expect that the D+O3 group will present: a) higher decreases in mean weight and body mass index (BMI), b) greater decreases in the mean fasting insulin concentration, homeostasis model assessment (HOMA) index, and IR frequency, c) longer duration of weight lost. Statistical analyses: Student and paired-t test will be used for inter and intra group comparisons respectively. Logistic regression models and repeated measures analyses will be conducted to evaluate the effect of treatments, adjusting by diet and weight loss, as well as by confounders such as puberty and treatment adherence. Infrastructure: The Unit of Research in Medical Nutrition owes the equipment needed to conduct the laboratory determinations proposed in this research, as well as the personnel qualified to conduct, monitor, analyze and evaluate data from field investigation, specially that related to obesity and IR.

Interventions

DIETARY_SUPPLEMENTOmega3 and an hypocaloric diet.

Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.

DIETARY_SUPPLEMENTSunflower oil with an hypocaloric diet.

Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.

Sponsors

Coordinación de Investigación en Salud, Mexico
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age between 12 and 18 years, * Male and female * Body mass Index (BMI) above the 95 percentile of the National Center for Health Statistics (NCHS) reference * Informed consent form signed by both parents or legal guardian.

Exclusion criteria

* Those diagnosed as with Diabetes Mellitus Type 2 (DMT2), Cardiovascular disease (CVD) or kidney disease * Those who are allergic to fish.

Design outcomes

Primary

MeasureTime frameDescription
Change in Insulin ResistanceAt baseline (at diagnosis), three months, throughout six months.Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through Homeostasis Model Assessment Index (HOMA), calculated by formula: (glucose, mg \* insulin,µU)/405. Where HOMA\>3.16 indicated insulin resistance index.

Secondary

MeasureTime frameDescription
Nutritional StatusAt baseline (at diagnosis), three months, throughout six months.Nutritional status was determined by registering body mass index (BMI) calculated by formula: kg/m\^2.

Other

MeasureTime frameDescription
Change in Insulin Resistance Through Fasting InsulinAt baseline (at diagnosis), three months, throughout six months.Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through fasting insulin (µU/mL)
Nutritional Status Through Waist CircumferenceAt baseline (at diagnosis), three months, throughout six months.Nutritional status was determined by registering waist circumference in cm.

Countries

Mexico

Participant flow

Recruitment details

Adolescents were recruited between July 2012 and December 2015, from three Family Medicine clinics of the Mexican Institute of Social Security (IMSS) in Mexico City.

Participants by arm

ArmCount
Omega 3 and an Hypocaloric Diet
Participants will receive a supplement containing omega 3: DHA and EPA fatty acids together with an hypocaloric diet. Omega3 and an hypocaloric diet.: Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.
119
Placebo
Participants will receive a supplement containing sunflower oil with an hypocaloric diet. Sunflower oil with an hypocaloric diet.: Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.
126
Total245

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIncomplete data42
Overall StudyLost to Follow-up14
Overall StudyReceived medication32
Overall StudyWithdrawal by Subject5649

Baseline characteristics

CharacteristicPlaceboTotalOmega 3 and an Hypocaloric Diet
Age, Categorical
<=18 years
126 Participants245 Participants119 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous13.58 years
STANDARD_DEVIATION 1.79
13.66 years
STANDARD_DEVIATION 1.87
13.73 years
STANDARD_DEVIATION 1.97
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Mexico
126 Participants245 Participants119 Participants
Sex: Female, Male
Female
69 Participants129 Participants60 Participants
Sex: Female, Male
Male
57 Participants116 Participants59 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1190 / 126
other
Total, other adverse events
0 / 1190 / 126
serious
Total, serious adverse events
0 / 1190 / 126

Outcome results

Primary

Change in Insulin Resistance

Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through Homeostasis Model Assessment Index (HOMA), calculated by formula: (glucose, mg \* insulin,µU)/405. Where HOMA\>3.16 indicated insulin resistance index.

Time frame: At baseline (at diagnosis), three months, throughout six months.

Population: Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.

ArmMeasureGroupValue (MEAN)Dispersion
Omega 3 and an Hypocaloric DietChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at baseline7.38 HOMA-IR IndexStandard Deviation 4.21
Omega 3 and an Hypocaloric DietChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at 3 mo6.73 HOMA-IR IndexStandard Deviation 3.71
Omega 3 and an Hypocaloric DietChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at 6 mo6.02 HOMA-IR IndexStandard Deviation 3.21
PlaceboChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at 3 mo6.28 HOMA-IR IndexStandard Deviation 3.53
PlaceboChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at baseline6.89 HOMA-IR IndexStandard Deviation 3.55
PlaceboChange in Insulin ResistanceHomeostasis Model Assessment (HOMA) at 6 mo5.41 HOMA-IR IndexStandard Deviation 3.21
Secondary

Nutritional Status

Nutritional status was determined by registering body mass index (BMI) calculated by formula: kg/m\^2.

Time frame: At baseline (at diagnosis), three months, throughout six months.

Population: Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.

ArmMeasureGroupValue (MEAN)Dispersion
Omega 3 and an Hypocaloric DietNutritional StatusBody Mass Index at baseline31.53 kg/m^2Standard Deviation 4.92
Omega 3 and an Hypocaloric DietNutritional StatusBody Mass Index at 3 months30.89 kg/m^2Standard Deviation 4.97
Omega 3 and an Hypocaloric DietNutritional StatusBody Mass Index at 6 months31.1 kg/m^2Standard Deviation 8.35
PlaceboNutritional StatusBody Mass Index at baseline31.16 kg/m^2Standard Deviation 3.79
PlaceboNutritional StatusBody Mass Index at 3 months30.40 kg/m^2Standard Deviation 3.79
PlaceboNutritional StatusBody Mass Index at 6 months30.25 kg/m^2Standard Deviation 3.95
Other Pre-specified

Change in Insulin Resistance Through Fasting Insulin

Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through fasting insulin (µU/mL)

Time frame: At baseline (at diagnosis), three months, throughout six months.

Population: Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.

ArmMeasureGroupValue (MEAN)Dispersion
Omega 3 and an Hypocaloric DietChange in Insulin Resistance Through Fasting InsulinFasting insulin at baseline33.05 µU/mLStandard Deviation 16.5
Omega 3 and an Hypocaloric DietChange in Insulin Resistance Through Fasting InsulinFasting insulin at 3 mo30.55 µU/mLStandard Deviation 15.52
Omega 3 and an Hypocaloric DietChange in Insulin Resistance Through Fasting InsulinFasting insulin at 6 mo29.40 µU/mLStandard Deviation 12.57
PlaceboChange in Insulin Resistance Through Fasting InsulinFasting insulin at baseline31.30 µU/mLStandard Deviation 15.05
PlaceboChange in Insulin Resistance Through Fasting InsulinFasting insulin at 3 mo29.09 µU/mLStandard Deviation 15.1
PlaceboChange in Insulin Resistance Through Fasting InsulinFasting insulin at 6 mo27.23 µU/mLStandard Deviation 12.63
Other Pre-specified

Nutritional Status Through Waist Circumference

Nutritional status was determined by registering waist circumference in cm.

Time frame: At baseline (at diagnosis), three months, throughout six months.

Population: Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.

ArmMeasureGroupValue (MEAN)Dispersion
Omega 3 and an Hypocaloric DietNutritional Status Through Waist CircumferenceWaist circumference at baseline100.44 cmStandard Deviation 12.37
Omega 3 and an Hypocaloric DietNutritional Status Through Waist CircumferenceWaist circumference at 3 months98.83 cmStandard Deviation 12.33
Omega 3 and an Hypocaloric DietNutritional Status Through Waist CircumferenceWaist circumference at 6 months96.99 cmStandard Deviation 11.68
PlaceboNutritional Status Through Waist CircumferenceWaist circumference at baseline99.40 cmStandard Deviation 9.81
PlaceboNutritional Status Through Waist CircumferenceWaist circumference at 3 months97.66 cmStandard Deviation 9.61
PlaceboNutritional Status Through Waist CircumferenceWaist circumference at 6 months97.11 cmStandard Deviation 10.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026