Transport of Artificial Sweeteners During Pregnancy
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状态招聘中
赞助商
University of Aarhus
临床试验: NCT03954418
BioSeek: NCT03954418
关键词
抽象
With obesity on the rise worldwide more and more young women are also affected, leading to a higher prevalence of obese pregnant women and pregnant women with diabetes.
Children of these women are in risk of developing obesity during childhood which again leads to overweight during adult life resulting in life-style related diseases such as diabetes and cardio-vascular disease.
Overweight and diabetic women are currently advised to substitute sugar sweetened beverages with artificially sweetened beverages to lower caloric intake and avoid fluctuations in blood glucose to avoid complications during pregnancy for both mother and child.
Recent studies suggest that high intake of artificial sweeteners during pregnancy increases the risk of the child developing obesity. If this is indeed true, the current guidelines have the opposite of the wanted and children already in risk of overweight are exposed to extra risk.
To investigate if artificial sweeteners can affect the foetus, the investigators wish to examine whether artificial sweeteners can cross the placenta.
The study is a clinical trial in which 40 women will be enrolled. 30 participants will drink a diet soft drink 2 hours before a caesarean section and 10 controls will refrain from intake. After birth the investigators will obtain a blood sample from the mother and from the umbilical cord and a placental biopsy and measure the contents of artificial sweeteners. Furthermore, the investigators will obtain a sample of amniotic fluid to examine if the sweeteners are excreted into the amniotic fluid.
The results ultimately have the potential to change the current guidelines on diet for overweight and diabetic women during pregnancy.
日期
| 最后验证: | 04/30/2019 |
| 首次提交: | 05/14/2019 |
| 提交的预估入学人数: | 05/14/2019 |
| 首次发布: | 05/16/2019 |
| 上次提交的更新: | 10/21/2019 |
| 最近更新发布: | 10/23/2019 |
| 实际学习开始日期: | 05/31/2019 |
| 预计主要完成日期: | 01/31/2020 |
| 预计完成日期: | 06/30/2020 |
状况或疾病
Pregnancy Related
Diabetes
IUGR
干预/治疗
Dietary Supplement: Intervention group
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Intervention group Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section. | Dietary Supplement: Intervention group Intervention group receives a combination of multiple artificial sweeteners |
| No Intervention: Control group Participants in the control group will refrain from intake of artificial sweeteners. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Elective caesarean section - Child with IUGR (10 subjects) - Diabetes (10 subjects) - Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls) Exclusion Criteria: - Acute caesarean section |
结果
主要结果指标
1. Mothers blood [Time of birth]
Concentration of artificial sweeteners in blood from the mother
2. Placenta [Time of birth]
Concentration of artificial sweeteners in placenta
3. Umbilical cord [Time of birth]
Concentration of artificial sweeteners in blood from umbilical cord
4. Amniotic fluid [Time of birth]
Concentration of artificial sweeteners in amniotic fluid
