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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-55
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age under 16 years or over 55 years

Multiple pregnancy

Non-snack consumers

Smokers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Almond Snack Intervention for Gestational Diabetes

    Other intervention

    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 intervention

    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.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Almond groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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

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.
2

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.
3

Glucose variability

Glucose SD, glucose CV

Time frame
Assessed on day 14 and 28 of the intervention.
4

Blood glucose indices

High and low blood glucose indices (HBGI \& LBGI)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

King's College London

Collaborator

Almond Board of California

Collaborator

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