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NCT Number: NCT07069855

Nutcracker: Can Almond Nut Consumption Improve Nocturnal Glycaemic Control in Women With Gestational Diabetes Mellitus?

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age under 16 years or over 55 years
  • Multiple pregnancy
  • Non-snack consumers
  • Smokers
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean daytime glucose 07.00-22.00h

    Time frame: Assessed on day 14 and day 28 of the intervention.

    Recommended glucose control target 3.5-7.8mmol/L, AUC <6.7mmol/L, AUC <7.8mmol/L

  2. Postprandial blood glucose

    Time frame: Assessed on day 14 and day 28 of the intervention.

    Mean postprandial blood glucose for 1, 2 & 4 hours after dinner.

  3. Glucose variability

    Time frame: Assessed on day 14 and 28 of the intervention.

    Glucose SD, glucose CV

  4. Blood glucose indices

    Time frame: Assessed on day 14 and 28 of the intervention.

    High and low blood glucose indices (HBGI & LBGI)

  5. HbA1c

    Time frame: Assessed on day 0 and day 28 of the intervention.

    Biochemical analysis of maternal blood

  6. Liver function

    Time frame: Assessed on day 0 and day 28 of the intervention.

    Biochemical analysis of maternal blood: gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST)

  7. Maternal metabolome (blood)

    Time frame: Assessed on day 0 and day 28 of the intervention.

    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.

  8. Maternal weight in kg

    Time frame: Assessed on day 0 and day 28 of the intervention.

    Maternal weight and height will be combined to report BMI in kg/m^2

  9. Dietary intake using questionnaire

    Time frame: Assessed on or around day 0 (x2), day 14 (x 2) and day 28 (x2) of the intervention.

    Assessment of dietary intake using Intake24, a validated digital dietary recall system based on the multiple-pass 24-hour recall

  10. Assessment of appetite on a Likert scale

    Time frame: Assessed on day 0, day 14, and day 28 of the intervention.

    Assessment of appetite on a 1-7 Likert scale (i.e., 1 = Not at all hungry, 7 = Extremely hungry)

  11. Physical activity using accelerometer

    Time frame: Assessed on days 0-28 of the intervention.

    The accelerometer will record physical activity, such as average time spent in moderate, low, and sedentary activity

  12. Stool

    Time frame: May be assessed on days 0, 14 and 28 of the intervention.

    (Optional) may be collected and stored for microbiome analysis

  13. Sleep quality using accelerometer

    Time frame: Assessed on days 0-28 of the intervention.

    The accelerometer will measure sleep quality, such as sleep duration

  14. Course of GDM

    Time frame: Assessed on days 0-28 of the intervention.

    If medication is required for glucose control, such as metformin or insulin (dose, time of initiation)

  15. Mode of delivery

    Time frame: Assessed at delivery.

  16. Acceptability of the intervention using questionnaire

    Time frame: Assessed on day 28 of the intervention.

    A dietary intervention acceptability questionnaire will be used to assess enjoyment, sensory aspects, gastrointestinal effects, palatability, and appetite sensations.

  17. Birthweight

    Time frame: Assessed at delivery.

  18. Neonatal head circumference

    Time frame: Assessed at delivery.

  19. Neonatal sex

    Time frame: Assessed at delivery.

  20. Gestational age

    Time frame: Assessed at delivery.

  21. Neonatal complications

    Time frame: Assessed at delivery.

  22. Maternal complications

    Time frame: Assessed at delivery.

  23. Labour onset checklist

    Time frame: Assessed at delivery.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Righton

CONTACT

[email protected]

Sara L White

CONTACT

[email protected]

+44 (0) 20 7188 8151

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Almond Board of California
  • King's College London

Registry information

Official study title

Nutcracker: Can Almond Nut Consumption Improve Nocturnal Glycaemic Control in Women With Gestational Diabetes Mellitus? A Randomised Controlled Trial

Acronym: Nutcracker

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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