Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Maternal Supraphysiological Hypercholesterolemia Extra Virgin Olive Oil as a Nutritional Intervention During Pregnancy to Reduce the Impact of This Maternal Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MaterLIP
Brief Summary:
The objective of this clinical trial is to know if supplementation with extra virgin olive oil EVOO during pregnancy improves the maternal and neonatal lipoprotein profile lipoprotein function oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia MSPH
The main questions to be answered are
1 Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy
2 Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy The investigators will compare regular diet supplemented with EVOO vs intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn
Participants
The recruited pregnant women will eat their normal diet control group or the same diet supplemented with 36 mL of EVOO daily EVOO group The protocol will be carried out from gestational week 28 to the end of pregnancy
A nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview
The recruited pregnant women will have the regular obstetric control every 4 weeks
At delivery a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis
The main questions to be answered are
1 Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy
2 Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy The investigators will compare regular diet supplemented with EVOO vs intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn
Participants
The recruited pregnant women will eat their normal diet control group or the same diet supplemented with 36 mL of EVOO daily EVOO group The protocol will be carried out from gestational week 28 to the end of pregnancy
A nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview
The recruited pregnant women will have the regular obstetric control every 4 weeks
At delivery a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis
Detailed Description:
HYPOTHESIS The nutritional supplementation with extra virgin olive oil EVOO enriched in polyphenols will improve the lipoprotein profile the oxidative status and the vascular dysfunction in the mother and the offspring affected by maternal supraphysiological hypercholesterolemia MSPH
AIM To determine the effects of the nutritional supplementation with EVOO during pregnancy on MSPH women evaluating the lipoprotein profile lipoprotein function the oxidative status and markers of vascular function in the mother and the offspring at birth
STUDY DESIGN This is a prospective longitudinal study that aims to recruit women from week 24th at moment where most pathological conditions of pregnancy has been diagnosed to week 27th of gestation These women will be supplemented with EVOO from the week 28th until term 12 weeks Previous studies have established that EVOO supplementation from week 28th until term reduced inflammatory markers in in pregnant women whit gestational diabetes mellitus An equivalent group of women without EVOO supplementation will be considered as control The participants will be from the Clínica Universidad de Los Andes CUA Recruitment and follow up Pregnant women that fulfill eligibility according to the inclusionexclusion criteria will be invited to participate in this study They will be informed of the details of the study and will be asked to sign an informed consent for the nutritional supplementation and the biological samples donation at end of pregnancy MPH pregnancies with maternal physiological hypercholesterolemia or control pregnancies or MSPH pregnancies with maternal supraphysiological hypercholesterolemia or pathological pregnancies will be classified at term of pregnancy according to blood TC levels obtained by qualified personal of the Department of Obstetrics and Gynecology at CUA under advisor of the Co- Investigator Dr Illanes Study groups 1 MPH 2 MPH EVOO 3 MSPH and 4 MSPH EVOO Inclusion criteria pregnant women with MPH or MSPH pregnancies with term pregnancies 37-weeks singleton pregnancies without fetal malformations will be considered Pregnant women with blood TC levels 280 mgdl will be classified as MPH and with TC levels ampampgt280 mgdl will be classified as MSPH This classification is based on the criteria reported in previous published studies
Exclusion criteria Patients with pre-gestational andor gestational diabetes mellitus obesity before or during pregnancy or those with pathological conditions eg pre-eclampsia pregnancy hypertensive syndrome and growth retardation will be excluded from the study
SUPPLEMENTATION The investigators will supplement the selected women with or without EVOO since week 28th of gestation However the classification as MPH or MSPH occur only at birth 37-weeks According to sample size calculation the estimated sample size is 18 subjects per group Thus 18 MSPH women supplemented with EVOO and 18 MSPH women not supplemented are required Considering that MSPH occurs in approximately 32 of the pregnant women data form the literature to obtain 36 MSPH women the investigators propose to recruit 120 women in total Thus from these 120 women is expected that 36 will be MSPH The other 84 women will be MPH and will be considered as control of the MSPH women The 120 women will be randomized in order of recruitment one by one as control or EVOO groups EVOO supplementation The women randomized to EVOO groups will be supplemented daily with 36 mL three tablespoons of EVOO with a concentration of phenolic compounds ampampgt 500 mgkg this concentration of phenols is non-toxic and highly effective according to the previous reports The supplementation will start at week 28th of gestation until the term 37-weeks following the published data of our collaborator Dra Jawerbaum EVOO will be indicated to be consumed uncooked and within the main meals as reported All the needed EVOO for the 12 weeks of protocol will be provided monthly to the participants to assure the correct quality of EVOO
EXTRA VIRGIN OLIVE OIL CHARACTERIZATION The EVOO for this project will be obtained from ALONSO TM EVOO producers that regularly determine the composition of EVOO to assure its quality According to previous publications the investigators will use EVOO from the varietal Coratina 700 mgKg1of polyphenols that present the higher concentration of phenolic compound compared with other varietals presents in Chile Considering that the polyphenolic composition of the varietals changes yearly according to the climatological conditions in collaboration with ALONSO producers the investigators will measure the lipidic and polyphenol composition in all the lots of EVOO required for the study
ADHERENCE AND FOLLOWING The dietary habits physical activity body mass determination and different anthropometric measurements will be obtained by physical examination and questionaries performed at the moment of recruitment and monthly by a nutritionist that support this project and works with Dr Illanes team in CUA Dra Peñailillo Adherence Adherence to the supplementation will be evaluated by questionaries Questionaries the EVOO consumption will be obtained after application of two nutritional questionaries to determine dietary habits 1 food frequency questionnaire FFQ and 2 mediterranean diet adherence screener MEDAS questionary developed and validated for Chilean population by the group of our Co-investigator Dr Rigotti The adherence will be considered Good if questionaries indicated a daily EVOO consumption over 26 gday 5 to 7 times per week As Regular if daily EVOO consumption was over 26 gday but only 3 or 4 times per week and Bad if daily EVOO consumption was lower than 26 gday or lower than 3 times per week Only Good adherence will be considered for the study In the sample size determination section the investigators considered that 25 of recruited women will be lost by low adherences classified ad regular or bad as reported in studies of EVOO supplementation
PARAMETERS TO BE EVALUATED At the end of pregnancy maternal and umbilical cord blood samples MPH MPH EVOO MSPH and MSPH EVOO will be obtained to evaluate the lipoprotein profile lipoprotein function oxidative status as well as markers of vascular dysfunction
EXPECTED RESULTS The aim of this protocol is to determine that the adherence Good to the EVOO supplementation protocol will reduce the oxidative status the markers of inflammation and endothelial dysfunction in the maternal and neonatal blood as well as in placental vessels promoting an anti-atherogenic lipoprotein profile and function without reduction of the total cholesterol levels As a second outcome of this aim the adherence determination by the dietary questionaries will also allow to determine the predisposition of this population pregnant women to a dietary intervention This data will be useful to propose bigger interventions in the future Finally it is expect to determine the association between EVOO supplementation and clinical parameters of pregnancy outcome weight gain blood pressure birth weight week of delivery
AIM To determine the effects of the nutritional supplementation with EVOO during pregnancy on MSPH women evaluating the lipoprotein profile lipoprotein function the oxidative status and markers of vascular function in the mother and the offspring at birth
STUDY DESIGN This is a prospective longitudinal study that aims to recruit women from week 24th at moment where most pathological conditions of pregnancy has been diagnosed to week 27th of gestation These women will be supplemented with EVOO from the week 28th until term 12 weeks Previous studies have established that EVOO supplementation from week 28th until term reduced inflammatory markers in in pregnant women whit gestational diabetes mellitus An equivalent group of women without EVOO supplementation will be considered as control The participants will be from the Clínica Universidad de Los Andes CUA Recruitment and follow up Pregnant women that fulfill eligibility according to the inclusionexclusion criteria will be invited to participate in this study They will be informed of the details of the study and will be asked to sign an informed consent for the nutritional supplementation and the biological samples donation at end of pregnancy MPH pregnancies with maternal physiological hypercholesterolemia or control pregnancies or MSPH pregnancies with maternal supraphysiological hypercholesterolemia or pathological pregnancies will be classified at term of pregnancy according to blood TC levels obtained by qualified personal of the Department of Obstetrics and Gynecology at CUA under advisor of the Co- Investigator Dr Illanes Study groups 1 MPH 2 MPH EVOO 3 MSPH and 4 MSPH EVOO Inclusion criteria pregnant women with MPH or MSPH pregnancies with term pregnancies 37-weeks singleton pregnancies without fetal malformations will be considered Pregnant women with blood TC levels 280 mgdl will be classified as MPH and with TC levels ampampgt280 mgdl will be classified as MSPH This classification is based on the criteria reported in previous published studies
Exclusion criteria Patients with pre-gestational andor gestational diabetes mellitus obesity before or during pregnancy or those with pathological conditions eg pre-eclampsia pregnancy hypertensive syndrome and growth retardation will be excluded from the study
SUPPLEMENTATION The investigators will supplement the selected women with or without EVOO since week 28th of gestation However the classification as MPH or MSPH occur only at birth 37-weeks According to sample size calculation the estimated sample size is 18 subjects per group Thus 18 MSPH women supplemented with EVOO and 18 MSPH women not supplemented are required Considering that MSPH occurs in approximately 32 of the pregnant women data form the literature to obtain 36 MSPH women the investigators propose to recruit 120 women in total Thus from these 120 women is expected that 36 will be MSPH The other 84 women will be MPH and will be considered as control of the MSPH women The 120 women will be randomized in order of recruitment one by one as control or EVOO groups EVOO supplementation The women randomized to EVOO groups will be supplemented daily with 36 mL three tablespoons of EVOO with a concentration of phenolic compounds ampampgt 500 mgkg this concentration of phenols is non-toxic and highly effective according to the previous reports The supplementation will start at week 28th of gestation until the term 37-weeks following the published data of our collaborator Dra Jawerbaum EVOO will be indicated to be consumed uncooked and within the main meals as reported All the needed EVOO for the 12 weeks of protocol will be provided monthly to the participants to assure the correct quality of EVOO
EXTRA VIRGIN OLIVE OIL CHARACTERIZATION The EVOO for this project will be obtained from ALONSO TM EVOO producers that regularly determine the composition of EVOO to assure its quality According to previous publications the investigators will use EVOO from the varietal Coratina 700 mgKg1of polyphenols that present the higher concentration of phenolic compound compared with other varietals presents in Chile Considering that the polyphenolic composition of the varietals changes yearly according to the climatological conditions in collaboration with ALONSO producers the investigators will measure the lipidic and polyphenol composition in all the lots of EVOO required for the study
ADHERENCE AND FOLLOWING The dietary habits physical activity body mass determination and different anthropometric measurements will be obtained by physical examination and questionaries performed at the moment of recruitment and monthly by a nutritionist that support this project and works with Dr Illanes team in CUA Dra Peñailillo Adherence Adherence to the supplementation will be evaluated by questionaries Questionaries the EVOO consumption will be obtained after application of two nutritional questionaries to determine dietary habits 1 food frequency questionnaire FFQ and 2 mediterranean diet adherence screener MEDAS questionary developed and validated for Chilean population by the group of our Co-investigator Dr Rigotti The adherence will be considered Good if questionaries indicated a daily EVOO consumption over 26 gday 5 to 7 times per week As Regular if daily EVOO consumption was over 26 gday but only 3 or 4 times per week and Bad if daily EVOO consumption was lower than 26 gday or lower than 3 times per week Only Good adherence will be considered for the study In the sample size determination section the investigators considered that 25 of recruited women will be lost by low adherences classified ad regular or bad as reported in studies of EVOO supplementation
PARAMETERS TO BE EVALUATED At the end of pregnancy maternal and umbilical cord blood samples MPH MPH EVOO MSPH and MSPH EVOO will be obtained to evaluate the lipoprotein profile lipoprotein function oxidative status as well as markers of vascular dysfunction
EXPECTED RESULTS The aim of this protocol is to determine that the adherence Good to the EVOO supplementation protocol will reduce the oxidative status the markers of inflammation and endothelial dysfunction in the maternal and neonatal blood as well as in placental vessels promoting an anti-atherogenic lipoprotein profile and function without reduction of the total cholesterol levels As a second outcome of this aim the adherence determination by the dietary questionaries will also allow to determine the predisposition of this population pregnant women to a dietary intervention This data will be useful to propose bigger interventions in the future Finally it is expect to determine the association between EVOO supplementation and clinical parameters of pregnancy outcome weight gain blood pressure birth weight week of delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None