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