Nutcracker: Can Almond Nut Consumption Improve Nocturnal Glycaemic Control in Women With Gestational Diabetes Mellitus? A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- Mean nocturnal blood glucose (22.00-07.00h)
研究概览
简要总结
Gestational diabetes, affecting over one in six births globally, is a growing public health concern. Characterised by high blood glucose, it increases the risk of pregnancy complications and raises the mother's long-term risk of type 2 diabetes. Managing high fasting glucose, which reflects elevated overnight levels, is a key challenge. Night-time snacking-more common in women with gestational diabetes-is linked to higher fasting glucose, but the impact of snack quality is unclear. Almonds have been shown to improve glucose control in non-pregnant adults. This study will test whether almonds, as a night-time snack, can improve overnight glucose levels in pregnant women with gestational diabetes. Findings could support a simple, effective dietary strategy to improve outcomes for mothers and babies worldwide.
详细描述
Gestational diabetes mellitus (GDM) is a significant and increasingly prevalent public health concern, affecting over one-sixth of births globally. A key challenge in its management is fasting hyperglycaemia, which may result from elevated nocturnal glucose concentrations. Nocturnal hyperglycaemia has been linked to an increased risk of large-for-gestational-age infants in women with GDM. These women are also more likely to snack at night, a behaviour associated with higher fasting glucose concentrations; however, the impact of snack quality on overnight glucose regulation remains unclear.
Almond consumption has been shown to improve glycaemia in individuals with prediabetes or type 2 diabetes, potentially through mechanisms such as carbohydrate displacement and the beneficial effects of their nutrient profile, particularly magnesium and monounsaturated fats. Despite this, research in pregnant populations-especially those with GDM-is limited.
This study will investigate whether consuming almonds as an evening snack for four weeks improves overnight glucose regulation in women with GDM. Participants will be randomised to receive either almonds or a nut-free, energy-matched control snack. Changes in glucose metabolism will be assessed to determine the potential role of almonds in dietary management of GDM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Statistician
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 16 years
- •Singleton pregnancy
- •25 to 31+6 weeks' gestation diagnosed with GDM using a standard clinical 75g oral glucose tolerance test (OGTT), as per the guidelines of the National Institute of Health and Care Excellence (NICE), and had their first post-diagnosis consultation (approx. 7-10 days later). The NICE criteria state that the diagnosis of GDM will be made with one or more glucose concentrations during the OGTT of >5.6 mmol/l in the fasting state; >7.8 mmol/l 2 hours after 75g glucose
- •Planned antenatal care at the same centre
- •GDm-Health (a digital app for the management of diabetes in pregnancy) used as part of their management for GDM
- •Willing and able to give informed consent
排除标准
- •Age under 16 years or over 55 years
- •Multiple pregnancy
- •Non-snack consumers
- •Women who would work night shifts over the study period
- •Women who have already commenced insulin for the treatment of GDM
- •Allergy or intolerance to nuts
- •Pre-existing medical conditions, including Type 1 or Type 2 diabetes, chronic coronary, renal or bowel disease or history of cholestatic liver disease or pancreatitis. Presence of gastrointestinal disorder or use of a drug which is likely to alter gastrointestinal motility or nutrient absorption, previous bariatric surgery
- •Unwilling or unable to give informed consent
研究组 & 干预措施
Almond group
Participants in the almond group will consume 43 g of almonds daily for 28 days, divided into two equal portions: one in the afternoon and one in the evening.
干预措施: Almond Snack Intervention for Gestational Diabetes (Other)
Control group
Participants in the control group will consume nut-free snacks (e.g., crackers or savoury biscuits) that are energy-matched to the almond snacks.
干预措施: Control (placebo) group (Other)
结局指标
主要结局
Mean nocturnal blood glucose (22.00-07.00h)
时间窗: The primary endpoint will be assessed on day 14 and day 28 of the intervention.
次要结局
- Gestational age(Assessed at delivery.)
- Mean daytime glucose 07.00-22.00h(Assessed on day 14 and day 28 of the intervention.)
- Postprandial blood glucose(Assessed on day 14 and day 28 of the intervention.)
- Glucose variability(Assessed on day 14 and 28 of the intervention.)
- Blood glucose indices(Assessed on day 14 and 28 of the intervention.)
- HbA1c(Assessed on day 0 and day 28 of the intervention.)
- Liver function(Assessed on day 0 and day 28 of the intervention.)
- Maternal metabolome (blood)(Assessed on day 0 and day 28 of the intervention.)
- Maternal weight in kg(Assessed on day 0 and day 28 of the intervention.)
- Dietary intake using questionnaire(Assessed on or around day 0 (x2), day 14 (x 2) and day 28 (x2) of the intervention.)
- Assessment of appetite on a Likert scale(Assessed on day 0, day 14, and day 28 of the intervention.)
- Physical activity using accelerometer(Assessed on days 0-28 of the intervention.)
- Stool(May be assessed on days 0, 14 and 28 of the intervention.)
- Sleep quality using accelerometer(Assessed on days 0-28 of the intervention.)
- Course of GDM(Assessed on days 0-28 of the intervention.)
- Mode of delivery(Assessed at delivery.)
- Acceptability of the intervention using questionnaire(Assessed on day 28 of the intervention.)
- Birthweight(Assessed at delivery.)
- Neonatal head circumference(Assessed at delivery.)
- Neonatal sex(Assessed at delivery.)
- Neonatal complications(Assessed at delivery.)
- Maternal complications(Assessed at delivery.)
- Labour onset checklist(Assessed at delivery.)