Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Concentration differences in blood glucose following an OGTT
研究概览
简要总结
The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided.
The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the intervention and placebo in the laboratory setting.
Quadruple (Participants, care providers, investigators and outcome assessors) Participants, care providers, investigators and outcome assessors will be blinded to the placebo and varying doses of whey in the home setting.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
- •BMI 20-35
- •Normal blood pressure
- •Age > 18 years
排除标准
- •Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet
- •Daily intake of protein supplements
- •Milk allergy or phenylketonuria
- •Celiac disease
- •Medication with effect on glucose metabolism e.g. steroid
- •Do not speak or understand Danish
- •Polycystic Ovarian Syndrome
- •PI finds the patient unfit (like mental illness, too nervous or other)
- •Anemia (hemoglobin <6 mmol/l)
- •Severe chronic illness
- •Depression
- •Severe nausea/vomiting
- •Non-breakfast eaters
结局指标
主要结局
Concentration differences in blood glucose following an OGTT
时间窗: 3 hours following the OGTT
次要结局
- Continuous glucose measurements (CGM)(5 days)
- Concentration differences in glucagon like peptide 1 (GLP-1)(3 hours following the OGTT)
- Concentration differences in ghrelin(3 hours following the OGTT)
- Self-reported appetite(3 hours following the OGTT and 3 hours following breakfast)
- Concentration differences in c-peptide(3 hours following the OGTT)
- Respiratory quotient (RQ)(3 hours following the OGTT)
- Energy expenditure(5 days)
- Activity(5 days)
- Concentration differences in glucose independent peptide (GIP)(3 hours following the OGTT)
- Concentration differences in glucagon(3 hours following the OGTT)
- Concentration differences in insulin(3 hours following the OGTT)
- Concentration differences in leptin(3 hours following the OGTT)
- Resting energy expenditure (REE) (Resting Metabolic Rate)(3 hours following the OGTT)
- Concentration differences in free fatty acids (FFA)(3 hours following the OGTT)
- Concentration differences in amino acids (AA)(3 hours following the OGTT)
- Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)(3 hours following the OGTT)
- Heart rate(5 days)