NCT06960967

Brief Summary

Nut consumption is known to improve health outcomes, such as reducing the risk of chronic diseases like diabetes, cognitive impairment, and cardiovascular diseases. While most research has focused on walnuts and almonds, there is limited information on the health benefits of chestnuts. Chestnuts are unique among tree nuts due to their high starch and fibre content, along with vitamins E and C, minerals (potassium, phosphorus, magnesium), and polyphenols. Evidence from in vitro and animal studies suggests that chestnuts may positively affect health by regulating the gut microbiome, lowering the glycaemic index, and providing antioxidant benefits. The food industry is also exploring new uses for chestnuts, particularly in gluten-free products, due to their nutritional benefits and good taste. Nonetheless, no research has investigated the health effects of chestnuts in humans. By addressing this gap in the literature, the study may lead to the development of new dietary strategies for improved health outcomes.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

April 29, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

chestnutspostprandial glycemiapostprandial insulinemiaglucose tolerance

Outcome Measures

Primary Outcomes (2)

  • Postprandial blood glucose incremental area under the curve (iAUC)

    Difference in postprandial blood glucose iAUC

    Three hour blood glucose iAUC will be calculated from nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.

  • Postprandial plasma insulin incremental area under the curve (iAUC)

    Difference in postprandial plasma insulin iAUC.

    Three hour insulin iAUC will be calculated from seven time points (0, 30, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.

Secondary Outcomes (3)

  • Postprandial glucose concentration

    Glucose concentration will be measured at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.

  • Postprandial insulin concentration

    Insulin concentration will be measured in finger prick blood samples at seven time points (0, 30, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.

  • Time to peak glucose

    Three hours

Study Arms (2)

Control meal

PLACEBO COMPARATOR

Participants will receive an isocaloric baked meal without chestnut flour.

Other: Control meal

Chestnut meal

EXPERIMENTAL

Participants will receive an isocaloric baked meal with chestnut flour.

Other: Chestnut meal

Interventions

Participants will receive an isocaloric baked meal with chestnut flour.

Chestnut meal

Participants will receive an isocaloric baked meal without chestnut flour.

Control meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18-65 years old
  • Available to attend two testing sessions at the research facility

You may not qualify if:

  • Allergy to nuts and/or gluten,
  • BMI\<18.5 or ≥30 kg/m2,
  • Fasting glucose \>5.6 mmol/L, presence of diabetes and/or taking anti-diabetic medication
  • Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery,
  • Smoker,
  • Cardiovascular disease
  • Pregnant or breastfeeding women
  • Presence of implanted cardiac defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The participants will be requested to attend 2 morning visits to the research centre to receive one of the test meals. These meals will be isocaloric with or without the addition of chestnut flour. The order in which they undertake the two test visits will be randomised.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

June 6, 2025

Primary Completion

August 18, 2025

Study Completion

April 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations