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Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases

Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00872365
Enrollment
320
Registered
2009-03-31
Start date
2011-03-31
Completion date
2012-03-31
Last updated
2018-10-15

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

Conditions

Exercise, Micronutrients, Preeclampsia, Pregnancy

Keywords

Pregnancy, Exercise, Nutrition, Micronutrients, non-transmissible chronic diseases, Endothelium

Brief summary

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.

Detailed description

Hypothesis: 1. There is correlation between the metabolic factors, related to non-transmissible chronic diseases, of the mother and those of the newborn one. 2. Supplementation with either micronutrients or physical exercise influence beneficially as much in the endothelial function, oxidative stress, the levels in adipokines of the mother and the newborn one like in the placental mitochondrial function. 3. The simultaneous intervention with micronutrients or physical exercise produces an additional beneficial effect in the metabolic state of the mother and the newborn one. 4. The metabolic alterations when being born are not exclusive of newborn with anthropometric measures located either in the inferior or superior percentiles.

Interventions

Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.

DIETARY_SUPPLEMENTMicronutrients

Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.

OTHERActivities of daily living + placebo

Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care. Placebo Comparator: Equivalent to placebo (maltodextrin).

Sponsors

Fundación FES
CollaboratorOTHER
Fundación Cardiovascular de Colombia
CollaboratorOTHER
Instituto Nacional de Salud
CollaboratorUNKNOWN
University College, London
CollaboratorOTHER
Universidad del Valle, Colombia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 30 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Endothelium-dependent flow mediated dilationBaseline / week 32-36 of gestation

Secondary

MeasureTime frame
Biomarkers of endothelial function in blood from umbilical vein and maternal bloodBaseline / 32-36 weeks gestation and delivery
Markers of mitochondrial functionBaseline / 32-36 weeks gestation and delivery
Neonatal and maternal anthropometric indicatorsBaseline / 32-36 weeks gestation and delivery
Quality of life SF-12Baseline / 32-36 weeks gestation and delivery
Functional capacity (VO2max)Baseline / 32-36 weeks gestation and delivery

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026