Nut Intake At Night: Effect on Postprandial Glycaemia

NCT04965896 | Withdrawn DMC

• 1 other identifier: Nut-night glucose response
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is some evidence to suggest that the timing of a meal intake directly impacts postprandial insulin and glucose responses, with meals consumed later during the day being more metabolically detrimental that the same meals consumed during the day. This information is particularly pertinent to the 16% of people employed in shift-work professions in Australia who have little choice but to eat during the late evening and overnight. The purpose of this study is to compare two effect of different meals or snacks (control vs test meal) on blood glucose and insulin at night time in healthy adults. This study will enable to develop suitable meals to consume at night time that can reduce the higher glucose and insulin responses that are a consequence of eating late into the night.

Conditions

Postprandial Hyperglycemia; Insulin Resistance

Keywords

glucose tolerance; meal timing; insulin; nuts; postprandial

Outcome Measures

Primary Outcomes (2)

• Postprandial plasma glucose area under the curve (iAUC)

  Difference in postprandial plasma glucose iAUC

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

• Postprandial plasma insulin iAUC

  Difference in postprandial plasma insulin iAUC

  Three hour glucose iAUC will be calculated at 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 plain white rice (75g of available carbohydrate) alongside a snack with crackers and cheese. The meal is similar in energy and macronutrients to the test meal.

Other: Control meal

Nut meal

EXPERIMENTAL

Participants will receive plain white rice (75g of available carbohydrate) alongside a portion of 30g of nuts. The meal is similar in energy and macronutrients to the control meal.

Other: Nut meal

Interventions

Control meal OTHER

Participants will receive plain white rice (75g of available carbohydrate) alongside a snack with crackers and cheese. The meal is similar in energy and macronutrients to the test meal.

Control meal

Nut meal OTHER

Participants will receive plain white rice (75g of available carbohydrate) alongside a portion of 30g of nuts. The meal is similar in energy and macronutrients to the control meal.

Nut meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 50 years of age
• Waist circumference of \<94cm and \<80cm for Caucasian males and females, respectively
• Waist circumference of \<90cm and \<80 cm for Asian males and females, respectively
• Available to attend two testing sessions at the research facility

You may not qualify if:

• Diagnosed with type 2 diabetes or taking anti-diabetic medication (oral hypoglycaemic agents)
• Impaired fasting glucose (≥ 7 mmol/L)
• Gastrointestinal conditions that may affect glycaemic response
• Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
• Women planning pregnancy, pregnant or lactating.

Sponsors & Collaborators

• Monash University: lead

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will complete 2 study sessions at night, consuming plain white rice (corresponding to 75g of available carbohydrate) alongside each test meal (either the nuts or control meal) on two separate occasions. The order of scheduling of the sessions will be randomised.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 16, 2021
• Study Start: December 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share