Pregnancy Clinical Trial
Official title:
Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
Verified date | October 2018 |
Source | Universidad del Valle, Colombia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
At the moment, most of efforts to prevent non-transmissible chronic diseases at population
level have been centered in promoting healthful behaviors like physical activity, consumption
of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in
adult population, but the results have been little hopeful. In the last years, manifold
studies have indicated the relation between metabolic alterations and of the fetal growth
with the development of non-transmissible chronic diseases in adult age. More recently, it
has been proposed that maternal factors (endothelial function, oxidative stress and
alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory
mechanisms of fetal metabolic alterations and of the later development of non-transmissible
chronic diseases. Also, it has been suggested that possibly supplementation with
micronutrients and the physical exercise during the gestation can regulate these maternal and
placental factors. For the reasons just mentioned, it is necessary to clarify if these
proposed factors are related to fetal metabolic alterations and if the supplementation during
the gestation with micronutrients and/or the physical exercise can regulate them, which would
be an early and novel alternative to fortify the prevention of non-transmissible chronic
diseases in the population.
Purpose
1. To evaluate the effect of associated both the maternal and placental metabolic factors
to non-transmissible chronic diseases in newborn.
2. To evaluate the effect of the physical exercise and the complementation with
micronutrients during the pregnancy either in the endothelial function, the levels of
adipokines, the oxidative stress of the mother and the newborn, as in the placental
mitochondrial function and the anthropometry of newborn.
Status | Completed |
Enrollment | 320 |
Est. completion date | March 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial. - Live fetus at the routine ultrasound scan and a normal pregnancy. - Gestational age 16 to 20 weeks - Written informed consent will be obtained from each woman prior to the inclusion in the study. Exclusion Criteria: - History of high blood pressure - Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases) - Persistent bleeding after week 12 of gestation - Poorly controlled thyroid disease - Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios - History of miscarriage in the last twelve months - Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003). |
Country | Name | City | State |
---|---|---|---|
Colombia | Ana C Plata, MSc | Cali | Valle Del Cauca |
Lead Sponsor | Collaborator |
---|---|
Universidad del Valle, Colombia | Fundación Cardiovascular de Colombia, Fundación FES, Instituto Nacional de Salud, University College, London |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelium-dependent flow mediated dilation | Baseline / week 32-36 of gestation | ||
Secondary | Biomarkers of endothelial function in blood from umbilical vein and maternal blood | Baseline / 32-36 weeks gestation and delivery | ||
Secondary | Markers of mitochondrial function | Baseline / 32-36 weeks gestation and delivery | ||
Secondary | Neonatal and maternal anthropometric indicators | Baseline / 32-36 weeks gestation and delivery | ||
Secondary | Quality of life SF-12 | Baseline / 32-36 weeks gestation and delivery | ||
Secondary | Functional capacity (VO2max) | Baseline / 32-36 weeks gestation and delivery |
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