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

U

Universidad del Valle, Colombia

Status

Completed

Conditions

Micronutrients
Preeclampsia
Exercise
Pregnancy

Treatments

Other: Activities of daily living + placebo
Dietary Supplement: Micronutrients
Behavioral: Regular aerobic physical exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00872365
Colciencias 110645921540

Details and patient eligibility

About

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.

Full description

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.

Enrollment

320 patients

Sex

Female

Ages

16 to 30 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

320 participants in 4 patient groups, including a placebo group

1
Other group
Description:
Regular aerobic physical exercise + placebo
Treatment:
Behavioral: Regular aerobic physical exercise
2
Other group
Description:
Activities of daily living + Micronutrients
Treatment:
Dietary Supplement: Micronutrients
3
Other group
Description:
Regular aerobic exercise + micronutrients
Treatment:
Behavioral: Regular aerobic physical exercise
Dietary Supplement: Micronutrients
4
Placebo Comparator group
Description:
Activities of daily living + placebo
Treatment:
Other: Activities of daily living + placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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