An interventional study of Almond Snack Intervention for Gestational Diabetes and Control (placebo) group in Gestational Diabetes, sponsored by Guy's and St Thomas' NHS Foundation Trust. Not yet recruiting. Open to female participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 156 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Almond Snack Intervention for Gestational Diabetes
Participants in the control group will consume nut-free snacks (e.g., crackers or savoury biscuits) that are energy-matched to the almond snacks.
Other: Control (placebo) group
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.
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.
Mean nocturnal blood glucose (22.00-07.00h)
Time frame: The primary endpoint will be assessed on day 14 and day 28 of the intervention.
Mean daytime glucose 07.00-22.00h
Recommended glucose control target 3.5-7.8mmol/L, AUC \<6.7mmol/L, AUC \<7.8mmol/L
Time frame: Assessed on day 14 and day 28 of the intervention.
Postprandial blood glucose
Mean postprandial blood glucose for 1, 2 \& 4 hours after dinner.
Time frame: Assessed on day 14 and day 28 of the intervention.
Glucose variability
Glucose SD, glucose CV
Time frame: Assessed on day 14 and 28 of the intervention.
Blood glucose indices
High and low blood glucose indices (HBGI \& LBGI)
Time frame: Assessed on day 14 and 28 of the intervention.
HbA1c
Biochemical analysis of maternal blood
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Assessed on days 0-28 of the intervention.
Stool
(Optional) may be collected and stored for microbiome analysis
Time frame: 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
Time frame: 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)
Time frame: Assessed on days 0-28 of the intervention.
Mode of delivery
Time frame: 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.
Time frame: Assessed on day 28 of the intervention.
Birthweight
Time frame: Assessed at delivery.
Neonatal head circumference
Time frame: Assessed at delivery.
Neonatal sex
Time frame: Assessed at delivery.
Gestational age
Time frame: Assessed at delivery.
Neonatal complications
Time frame: Assessed at delivery.
Maternal complications
Time frame: Assessed at delivery.
Labour onset checklist
Time frame: Assessed at delivery.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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