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Nut Intake at Night: Effect on Postprandial Glycaemia

Primary Purpose

Postprandial Hyperglycemia, Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control meal
Nut meal
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postprandial Hyperglycemia focused on measuring glucose tolerance, meal timing, insulin, nuts, postprandial

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control meal

    Nut meal

    Arm Description

    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 portion of 30g of nuts. The meal is similar in energy and macronutrients to the control meal.

    Outcomes

    Primary Outcome Measures

    Postprandial plasma glucose area under the curve (iAUC)
    Difference in postprandial plasma glucose iAUC
    Postprandial plasma insulin iAUC
    Difference in postprandial plasma insulin iAUC

    Secondary Outcome Measures

    Postprandial glucose concentration
    Difference in postprandial glucose concentration
    Postprandial insulin concentration
    Difference in postprandial insulin concentration
    Time to peak glucose
    Difference in time to peak glucose

    Full Information

    First Posted
    July 8, 2021
    Last Updated
    July 16, 2021
    Sponsor
    Monash University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04965896
    Brief Title
    Nut Intake at Night: Effect on Postprandial Glycaemia
    Official Title
    The Effect of Nut Intake at Night on Postprandial Glycaemia: a Randomised Crossover Trial in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    November 30, 2021 (Anticipated)
    Study Completion Date
    November 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Monash University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postprandial Hyperglycemia, Insulin Resistance
    Keywords
    glucose tolerance, meal timing, insulin, nuts, postprandial

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control meal
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Nut meal
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control meal
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Nut meal
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Postprandial plasma glucose area under the curve (iAUC)
    Description
    Difference in postprandial plasma glucose 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.
    Title
    Postprandial plasma insulin iAUC
    Description
    Difference in 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.
    Secondary Outcome Measure Information:
    Title
    Postprandial glucose concentration
    Description
    Difference in 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.
    Title
    Postprandial insulin concentration
    Description
    Difference in 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.
    Title
    Time to peak glucose
    Description
    Difference in time to peak glucose
    Time Frame
    Three hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barbara Rita Cardoso, PhD
    Phone
    +61 3 9902 4264
    Email
    barbara.cardoso@monash.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maxine Bonham, PhD
    Phone
    +61 3 9902 4272
    Email
    maxine.bonham@monash.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Nut Intake at Night: Effect on Postprandial Glycaemia

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