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

NCT07069855 | Not Yet Recruiting DMC

• 1 other identifier: 325804
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; pregnancy nutrition; dietary intervention

Outcome Measures

Primary Outcomes (1)

• Mean nocturnal blood glucose (22.00-07.00h)

  The primary endpoint will be assessed on day 14 and day 28 of the intervention.

Secondary Outcomes (23)

• Mean daytime glucose 07.00-22.00h

  Assessed on day 14 and day 28 of the intervention.

• Postprandial blood glucose

  Assessed on day 14 and day 28 of the intervention.

• Glucose variability

  Assessed on day 14 and 28 of the intervention.

• Blood glucose indices

  Assessed on day 14 and 28 of the intervention.

• HbA1c

  Assessed on day 0 and day 28 of the intervention.

Study Arms (2)

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.

Other: Almond Snack Intervention for Gestational Diabetes

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.

Other: Control (placebo) group

Interventions

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.

Almond group

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.

Control group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age over 16 years
• Singleton pregnancy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Almond Board of California: collaborator

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Sara L White

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara L White

CONTACT

+44 (0) 20 7188 8151; sara.white@kcl.ac.uk

Olivia Righton

CONTACT

olivia.k.righton@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07