Trials / Completed
CompletedNCT04190511
Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy
Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 375 (actual)
- Sponsor
- Capital Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.
Conditions
- Gestational Diabetes Mellitus
- Medical Nutrition Therapy
- Overweight/Obese
- Gut Microbiota
- Adverse Pregnancy Outcomes
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Prebiotic-containing dairy | The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day). |
| DIETARY_SUPPLEMENT | Dietary intervention | The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. |
Timeline
- Start date
- 2019-12-10
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2019-12-09
- Last updated
- 2021-08-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04190511. Inclusion in this directory is not an endorsement.