Trial Outcomes & Findings for Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents (NCT NCT01456221)
NCT ID: NCT01456221
Last Updated: 2024-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
366 participants
Primary outcome timeframe
At baseline (at diagnosis), three months, throughout six months.
Results posted on
2024-02-08
Participant Flow
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.
Participant milestones
| Measure |
Omega 3 and an Hypocaloric Diet
Participants will receive a supplement containing omega 3: Docosahexaenoic acid (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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
183
|
|
Overall Study
COMPLETED
|
119
|
126
|
|
Overall Study
NOT COMPLETED
|
64
|
57
|
Reasons for withdrawal
| Measure |
Omega 3 and an Hypocaloric Diet
Participants will receive a supplement containing omega 3: Docosahexaenoic acid (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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
56
|
49
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Received medication
|
3
|
2
|
|
Overall Study
Incomplete data
|
4
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omega 3 and an Hypocaloric Diet
n=119 Participants
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.
|
Placebo
n=126 Participants
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.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
119 Participants
n=119 Participants
|
126 Participants
n=126 Participants
|
245 Participants
n=245 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=119 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=245 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=119 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=245 Participants
|
|
Age, Continuous
|
13.73 years
STANDARD_DEVIATION 1.97 • n=119 Participants
|
13.58 years
STANDARD_DEVIATION 1.79 • n=126 Participants
|
13.66 years
STANDARD_DEVIATION 1.87 • n=245 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=119 Participants
|
69 Participants
n=126 Participants
|
129 Participants
n=245 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=119 Participants
|
57 Participants
n=126 Participants
|
116 Participants
n=245 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
119 Participants
n=119 Participants
|
126 Participants
n=126 Participants
|
245 Participants
n=245 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Omega 3 and an Hypocaloric Diet
n=119 Participants
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.
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Change in Insulin Resistance
Homeostasis Model Assessment (HOMA) at baseline
|
7.38 HOMA-IR Index
Standard Deviation 4.21
|
6.89 HOMA-IR Index
Standard Deviation 3.55
|
|
Change in Insulin Resistance
Homeostasis Model Assessment (HOMA) at 3 mo
|
6.73 HOMA-IR Index
Standard Deviation 3.71
|
6.28 HOMA-IR Index
Standard Deviation 3.53
|
|
Change in Insulin Resistance
Homeostasis Model Assessment (HOMA) at 6 mo
|
6.02 HOMA-IR Index
Standard Deviation 3.21
|
5.41 HOMA-IR Index
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: 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.
Nutritional status was determined by registering body mass index (BMI) calculated by formula: kg/m\^2.
Outcome measures
| Measure |
Omega 3 and an Hypocaloric Diet
n=119 Participants
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.
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Nutritional Status
Body Mass Index at baseline
|
31.53 kg/m^2
Standard Deviation 4.92
|
31.16 kg/m^2
Standard Deviation 3.79
|
|
Nutritional Status
Body Mass Index at 3 months
|
30.89 kg/m^2
Standard Deviation 4.97
|
30.40 kg/m^2
Standard Deviation 3.79
|
|
Nutritional Status
Body Mass Index at 6 months
|
31.1 kg/m^2
Standard Deviation 8.35
|
30.25 kg/m^2
Standard Deviation 3.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through fasting insulin (µU/mL)
Outcome measures
| Measure |
Omega 3 and an Hypocaloric Diet
n=119 Participants
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.
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Change in Insulin Resistance Through Fasting Insulin
Fasting insulin at baseline
|
33.05 µU/mL
Standard Deviation 16.50
|
31.30 µU/mL
Standard Deviation 15.05
|
|
Change in Insulin Resistance Through Fasting Insulin
Fasting insulin at 3 mo
|
30.55 µU/mL
Standard Deviation 15.52
|
29.09 µU/mL
Standard Deviation 15.10
|
|
Change in Insulin Resistance Through Fasting Insulin
Fasting insulin at 6 mo
|
29.40 µU/mL
Standard Deviation 12.57
|
27.23 µU/mL
Standard Deviation 12.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Nutritional status was determined by registering waist circumference in cm.
Outcome measures
| Measure |
Omega 3 and an Hypocaloric Diet
n=119 Participants
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.
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Nutritional Status Through Waist Circumference
Waist circumference at baseline
|
100.44 cm
Standard Deviation 12.37
|
99.40 cm
Standard Deviation 9.81
|
|
Nutritional Status Through Waist Circumference
Waist circumference at 3 months
|
98.83 cm
Standard Deviation 12.33
|
97.66 cm
Standard Deviation 9.61
|
|
Nutritional Status Through Waist Circumference
Waist circumference at 6 months
|
96.99 cm
Standard Deviation 11.68
|
97.11 cm
Standard Deviation 10.10
|
Adverse Events
Omega 3 and an Hypocaloric Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mardia Guadalupe Lopez Alarcon
Coordinacion de Investigacion en Salud, Mexico
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place