Nutrition and Pregnancy Intervention Study

Turku University Hospital (TYKS)

Status: Completed

Conditions: Cognitive Developmental Disorders; Gestational Diabetes Mellitus; Type2 Diabetes; Eating Behavior; Neurodevelopmental Disorders; Adiposity; Obesity; Cardiovascular Risk Factor; Liver Diseases; Pregnancy

Treatments: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01922791

T166/2012

Details and patient eligibility

About

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery.

The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated.

Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.

Enrollment: 439 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pregnant, less than 17 gestational weeks
• overweight
• healthy

Exclusion criteria

• Diabetes (type 1 or 2)
• Coeliac disease
• Increased bleeding tendency

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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439 participants in 4 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Comparison of probiotics, fish oil and their combination to placebo

Treatment:

Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo

Fish oil

Active Comparator group

Description:

Comparison of probiotics, fish oil and their combination to placebo

Treatment:

Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo

Probiotics and Fish oil

Active Comparator group

Description:

Comparison of probiotics, fish oil and their combination to placebo

Treatment:

Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo

Placebo

Placebo Comparator group

Description:

Comparison of probiotics, fish oil and their combination to placebo

Treatment:

Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo