Nut Intake at Night: Effect on Postprandial Glycaemia

July 16, 2021 updated by: Barbara R. Cardoso, Monash University

The Effect of Nut Intake at Night on Postprandial Glycaemia: a Randomised Crossover Trial in Healthy Adults

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.

Study Overview

Status

Not yet recruiting

Detailed Description

Eating in the morning results in a more effective clearance of blood sugar (glucose). However, some people, such as shift workers, have no choice but to eat at night. Previous studies have shown that consuming protein at night can be effective at lowering blood sugar. The investigators here propose that nuts would be a healthy snack to eat at night time as they are a good source of protein and may help to reduce the high levels of blood glucose observed by eating at night time.

The aim of this cross-over study is to compare the effect of a snack high in nuts compared with a control snack similar in macronutrients (cheese and crackers) on postprandial blood glucose and insulin in healthy participants after consumption of a meal known to raise blood sugar (white rice). The investigators hypothesise that compared with a standard snack, a snack containing nuts will show a lower postprandial glucose and insulin response.

The participants will complete an initial screening questionnaire to check eligibility. Eligible participants will attend the research facilities after 5h fasting at night (from 18.30pm-22.00pm) on two occasions, when they will receive plain white rice (75g of available carbohydrate) alongside either 30 g of mixed nuts (test meal) or a snack with cheese and crackers (control meal) that is equivalent in energy and macronutrient content. During the visits, a finger prick fasting glucose sample will be collected. Repeated finger prick samples will be collected at 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the meal intake. These samples will be used for glucose and insulin measurement. Postprandial glucose and insulin iAUC will be calculated. Differences in glucose and insulin concentrations and iAUC as well as glucose time to peak will be compared between the two treatment conditions.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control meal
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.
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.
Experimental: Nut meal
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial plasma glucose area under the curve (iAUC)
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose concentration
Time Frame: 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.
Difference in 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
Time Frame: 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.
Difference in 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
Time Frame: Three hours
Difference in time to peak glucose
Three hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Nut-night glucose response

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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