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

NCT00872365 | Completed DMC

• 1 other identifier: Colciencias 110645921540
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the effect of associated both the maternal and placental metabolic factors to non-transmissible chronic diseases in newborn.
2. 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.

Conditions

Preeclampsia; Pregnancy; Micronutrients; Exercise

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Endothelium-dependent flow mediated dilation

  Baseline / week 32-36 of gestation

Secondary Outcomes (5)

• Biomarkers of endothelial function in blood from umbilical vein and maternal blood

  Baseline / 32-36 weeks gestation and delivery

• Markers of mitochondrial function

  Baseline / 32-36 weeks gestation and delivery

• Neonatal and maternal anthropometric indicators

  Baseline / 32-36 weeks gestation and delivery

• Quality of life SF-12

  Baseline / 32-36 weeks gestation and delivery

• Functional capacity (VO2max)

  Baseline / 32-36 weeks gestation and delivery

Study Arms (4)

1

OTHER

Regular aerobic physical exercise + placebo

Behavioral: Regular aerobic physical exercise

2

OTHER

Activities of daily living + Micronutrients

Dietary Supplement: Micronutrients

3

OTHER

Regular aerobic exercise + micronutrients

Behavioral: Regular aerobic physical exercise; Dietary Supplement: Micronutrients

4

PLACEBO COMPARATOR

Activities of daily living + placebo

Other: Activities of daily living + placebo

Interventions

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.

Also known as: Intervention I

1; 3

Micronutrients DIETARY_SUPPLEMENT

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

Also known as: Intervention II

2; 3

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).

4

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead
• Fundación FES: collaborator
• Fundación Cardiovascular de Colombia: collaborator
• Instituto Nacional de Salud: collaborator
• University College, London: collaborator

Study Sites (1)

Ana C Plata, MSc

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (2)

• Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, Ramirez-Velez R. Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. J Physiother. 2012;58(1):9-15. doi: 10.1016/S1836-9553(12)70067-X.

  PMID: 22341377 DERIVED

• Ramirez-Velez R, Romero M, Echeverri I, Ortega JG, Mosquera M, Salazar B, Giron SL, Saldarriaga W, Aguilar de Plata AC, Mateus JC. A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn. Trials. 2011 Feb 28;12:60. doi: 10.1186/1745-6215-12-60.

  PMID: 21356082 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Motor Activity

Interventions

Micronutrients; Methods; Activities of Daily Living

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ana C Plata, MSc

  Universidad del Valle, Colombia

  STUDY CHAIR

• Julio Cesar Mateus, MD, MEpi

  Fundación FES, División de Salud. Colombia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 31, 2009
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CO (1)