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This study will assess the feasibility of a randomized control trial in which the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation, as well offspring gene expression and body composition are examined.
Maternal obesity leads to increased insulin resistance and inflammation which have been shown to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic supplementation during pregnancy has been shown to improve insulin sensitivity in normal weight women. However, little is known on the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene expression and body composition. Long term nutritional supplementation, however, is associated with increased participant burden as well as lower compliance and retention rates. Thus, this study will assess the feasibility of a long term probiotic supplementation study in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy and study procedures will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Each probiotic capsule contains 180 mg of a standardized white to light beige fine powder consisting of freeze-dried cultures. Specifically, Bifidobacterium BB-12® and Lactobacillus rhamnosus LGG® (50%:50%). This product has a minimum potency of 6.5 billion (6.5E+9) CFU (ColonyForming Units) per capsule. Other ingredients in the powder are: microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate. Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery. |
|
| Placebo | Placebo Comparator | Participants in this group will take one capsule containing microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate (all ingredients listed in the probiotic capsules except the culture) . Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in acceptance of probiotic supplementation throughout pregnancy in obese women. | Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures. | Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 |
| Change in compliance with probiotic supplementation throughout pregnancy in obese women. | Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count. | Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 |
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Inclusion Criteria:
Exclusion Criteria:
• Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid disorders, heart disease or immune disorders) as determined by the PI to affect the outcomes of interest
This study is on pregnant women.
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| Name | Affiliation | Role |
|---|---|---|
| Eva C Diaz Fuentes, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Nutrition Center | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20089774 | Background | Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor M, Garaiova I, Plummer SF, Wang D, Morgan G. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr. 2010 Mar;140(3):483-8. doi: 10.3945/jn.109.117093. Epub 2010 Jan 20. | |
| 19646321 |
| Label | URL |
|---|---|
| Arkansas Children's Nutrition Center website | View source |
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No individual participant data will be shared with other researchers.
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | capsule manufactured to mimic probiotic capsules. |
|
| Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9. |
| 20970896 | Background | Ilmonen J, Isolauri E, Poussa T, Laitinen K. Impact of dietary counselling and probiotic intervention on maternal anthropometric measurements during and after pregnancy: a randomized placebo-controlled trial. Clin Nutr. 2011 Apr;30(2):156-64. doi: 10.1016/j.clnu.2010.09.009. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |
| D019602 |
| Food and Beverages |