Trials / Completed
CompletedNCT00872365
Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- Universidad del Valle, Colombia · Academic / Other
- Sex
- Female
- Age
- 16 Years – 30 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Regular aerobic physical exercise | 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_SUPPLEMENT | Micronutrients | Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg. |
| OTHER | Activities 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). |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2011-11-01
- Completion
- 2012-03-01
- First posted
- 2009-03-31
- Last updated
- 2018-10-15
Locations
1 site across 1 country: Colombia
Source: ClinicalTrials.gov record NCT00872365. Inclusion in this directory is not an endorsement.