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Trial record 8 of 13 for:    probiotics | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Diabetes Mellitus

Nutrition and Pregnancy Intervention Study

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ClinicalTrials.gov Identifier: NCT01922791
Recruitment Status : Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Kirsi Laitinen, University of Turku

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pregnancy Obesity Gestational Diabetes Mellitus Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Placebo-controlled Intervention Study for Maternal and Child Health
Actual Study Start Date : October 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Active Comparator: Probiotic
Comparison of probiotics, fish oil and their combination to placebo
Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Double-blind randomized placebo controlled intervention
Other Names:
  • Lactobacillus and Bifidobacterium
  • Fish oil
  • Placebo, microcrystalline cellulose
  • Placebo, medium-chain triglycerides

Active Comparator: Fish oil
Comparison of probiotics, fish oil and their combination to placebo
Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Double-blind randomized placebo controlled intervention
Other Names:
  • Lactobacillus and Bifidobacterium
  • Fish oil
  • Placebo, microcrystalline cellulose
  • Placebo, medium-chain triglycerides

Active Comparator: Probiotics and Fish oil
Comparison of probiotics, fish oil and their combination to placebo
Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Double-blind randomized placebo controlled intervention
Other Names:
  • Lactobacillus and Bifidobacterium
  • Fish oil
  • Placebo, microcrystalline cellulose
  • Placebo, medium-chain triglycerides

Placebo Comparator: Placebo
Comparison of probiotics, fish oil and their combination to placebo
Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Double-blind randomized placebo controlled intervention
Other Names:
  • Lactobacillus and Bifidobacterium
  • Fish oil
  • Placebo, microcrystalline cellulose
  • Placebo, medium-chain triglycerides




Primary Outcome Measures :
  1. Prevalence of gestational diabetes mellitus, GDM [ Time Frame: Assessed at gestational weeks 24-28 ]
  2. Fasting glucose levels [ Time Frame: assessed at the third trimester of pregnancy ]
  3. Prevalence of allergy in child [ Time Frame: assessed at 12 and 24 months of age ]

Secondary Outcome Measures :
  1. Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin) [ Time Frame: During pregnancy ]
  2. Body composition of mother [ Time Frame: During and after pregnancy ]
  3. Immunologic and metabolic markers [ Time Frame: During and after pregnancy ]
  4. Fecal microbiota [ Time Frame: Before, during and after intervention ]

Other Outcome Measures:
  1. Body composition, growth, development and metabolic markers of the child [ Time Frame: 0 to 24 months of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922791


Locations
Finland
University of Turku
Turku, Finland, 20014
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
Principal Investigator: Kirsi Laitinen University of Turku

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kirsi Laitinen, Adjunct professor, University of Turku
ClinicalTrials.gov Identifier: NCT01922791     History of Changes
Other Study ID Numbers: T166/2012
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Kirsi Laitinen, University of Turku:
Nutrition
Probiotics
Fish oil

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications