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| Name | Class |
|---|---|
| King's College London | OTHER |
| Almond Board of California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond group | Experimental | 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. |
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| Control group | Placebo Comparator | Participants in the control group will consume nut-free snacks (e.g., crackers or savoury biscuits) that are energy-matched to the almond snacks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond Snack Intervention for Gestational Diabetes | Other | This intervention involves daily consumption of 43 g of whole almonds, split into two portions (afternoon and evening), for 28 days in pregnant women diagnosed with gestational diabetes who habitually consume evening snacks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean nocturnal blood glucose (22.00-07.00h) | The primary endpoint will be assessed on day 14 and day 28 of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daytime glucose 07.00-22.00h | Recommended glucose control target 3.5-7.8mmol/L, AUC <6.7mmol/L, AUC <7.8mmol/L | Assessed on day 14 and day 28 of the intervention. |
| Postprandial blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara L White | Contact | +44 (0) 20 7188 8151 | sara.white@kcl.ac.uk | |
| Olivia Righton | Contact | olivia.k.righton@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sara L White | King's College London | Principal Investigator |
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Randomised controlled trial
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Statistician
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| Control (placebo) group | Other | This control involves the daily consumption of a nut-free snack (2 portions) that reflects a 'typical snack' choice among pregnant women with gestational diabetes. It serves as a comparison to assess the specific impact of almond-based evening snacking on overnight glucose regulation. |
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Mean postprandial blood glucose for 1, 2 & 4 hours after dinner.
| Assessed on day 14 and day 28 of the intervention. |
| Glucose variability | Glucose SD, glucose CV | Assessed on day 14 and 28 of the intervention. |
| Blood glucose indices | High and low blood glucose indices (HBGI & LBGI) | Assessed on day 14 and 28 of the intervention. |
| HbA1c | Biochemical analysis of maternal blood | Assessed on day 0 and day 28 of the intervention. |
| Liver function | Biochemical analysis of maternal blood: gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) | Assessed on day 0 and day 28 of the intervention. |
| Maternal metabolome (blood) | Lipid measures, including lipoprotein particles (VLDL subdivided into six subclasses, IDL, LDL subdivided into three subclasses, and HDL subdivided into four subclasses), constituents within each lipoprotein particle type (triglycerides, total cholesterol, free cholesterol and cholesterol ester levels and phospholipid concentrations), fatty acids, amino acids, glycolysis related metabolites, ketone bodies and inflammatory markers. | Assessed on day 0 and day 28 of the intervention. |
| Maternal weight in kg | Maternal weight and height will be combined to report BMI in kg/m^2 | Assessed on day 0 and day 28 of the intervention. |
| Dietary intake using questionnaire | Assessment of dietary intake using Intake24, a validated digital dietary recall system based on the multiple-pass 24-hour recall | 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 | Assessment of appetite on a 1-7 Likert scale (i.e., 1 = Not at all hungry, 7 = Extremely hungry) | Assessed on day 0, day 14, and day 28 of the intervention. |
| Physical activity using accelerometer | The accelerometer will record physical activity, such as average time spent in moderate, low, and sedentary activity | Assessed on days 0-28 of the intervention. |
| Stool | (Optional) may be collected and stored for microbiome analysis | May be assessed on days 0, 14 and 28 of the intervention. |
| Sleep quality using accelerometer | The accelerometer will measure sleep quality, such as sleep duration | Assessed on days 0-28 of the intervention. |
| Course of GDM | If medication is required for glucose control, such as metformin or insulin (dose, time of initiation) | Assessed on days 0-28 of the intervention. |
| Mode of delivery | Assessed at delivery. |
| Acceptability of the intervention using questionnaire | A dietary intervention acceptability questionnaire will be used to assess enjoyment, sensory aspects, gastrointestinal effects, palatability, and appetite sensations. | Assessed on day 28 of the intervention. |
| Birthweight | Assessed at delivery. |
| Neonatal head circumference | Assessed at delivery. |
| Neonatal sex | Assessed at delivery. |
| Gestational age | Assessed at delivery. |
| Neonatal complications | Assessed at delivery. |
| Maternal complications | Assessed at delivery. |
| Labour onset checklist | Assessed at delivery. |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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