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

NCT ID: NCT07069855

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Almond Snack Intervention for Gestational Diabetes

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

Control (placebo) group

Intervention Type: 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.

Interventions

Almond Snack Intervention for Gestational Diabetes

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.

Intervention Type: OTHER

Control (placebo) group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age over 16 years

2. Singleton pregnancy

3. 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

4. Planned antenatal care at the same centre

5. GDm-Health (a digital app for the management of diabetes in pregnancy) used as part of their management for GDM

6. Willing and able to give informed consent

Exclusion Criteria

1. Age under 16 years or over 55 years

2. Multiple pregnancy

3. Non-snack consumers

4. Smokers

5. Women who would work night shifts over the study period

6. Women who have already commenced insulin for the treatment of GDM

7. Allergy or intolerance to nuts

8. 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

9. Unwilling or unable to give informed consent

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Almond Board of California

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara L White

Role: PRINCIPAL_INVESTIGATOR

King's College London

Central Contacts

Sara L White

Role: CONTACT

sara.white@kcl.ac.uk

+44 (0) 20 7188 8151

Olivia Righton

Role: CONTACT

olivia.k.righton@kcl.ac.uk

Other Identifiers

325804

Identifier Type: -

Identifier Source: org_study_id