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NCT Number: NCT00872365

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

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.

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Key information

Conditions

Preeclampsia Behavior Exercise Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Micronutrients Motor Activity Pre-Eclampsia Pregnancy Pregnancy Complications Urogenital Diseases

Age range

16 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ana C Plata, MSc

Cali, Valle del Cauca Department, Colombia

About this study

Hypothesis:

  • There is correlation between the metabolic factors, related to non-transmissible chronic diseases, of the mother and those of the newborn one.
  • 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.
  • The simultaneous intervention with micronutrients or physical exercise produces an additional beneficial effect in the metabolic state of the mother and the newborn one.
  • The metabolic alterations when being born are not exclusive of newborn with anthropometric measures located either in the inferior or superior percentiles.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Regular aerobic physical exercise

Behavioral

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.

Other names: Intervention I

Micronutrients

Dietary Supplement

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

Other names: Intervention II

Activities of daily living + placebo

Other

Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care.

Placebo Comparator: Equivalent to placebo (maltodextrin).

Primary outcomes

  1. Endothelium-dependent flow mediated dilation

    Time frame: Baseline / week 32-36 of gestation

Secondary outcomes

  1. Biomarkers of endothelial function in blood from umbilical vein and maternal blood

    Time frame: Baseline / 32-36 weeks gestation and delivery

  2. Markers of mitochondrial function

    Time frame: Baseline / 32-36 weeks gestation and delivery

  3. Neonatal and maternal anthropometric indicators

    Time frame: Baseline / 32-36 weeks gestation and delivery

  4. Quality of life SF-12

    Time frame: Baseline / 32-36 weeks gestation and delivery

  5. Functional capacity (VO2max)

    Time frame: Baseline / 32-36 weeks gestation and delivery

Sponsors and collaborators

Lead sponsor

Universidad del Valle, Colombia

Other

Collaborators

  • Fundación Cardiovascular de Colombia
  • Fundación FES
  • Instituto Nacional de Salud
  • University College, London

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 31, 2009
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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