- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965896
Nut Intake at Night: Effect on Postprandial Glycaemia
The Effect of Nut Intake at Night on Postprandial Glycaemia: a Randomised Crossover Trial in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara Rita Cardoso, PhD
- Phone Number: +61 3 9902 4264
- Email: barbara.cardoso@monash.edu
Study Contact Backup
- Name: Maxine Bonham, PhD
- Phone Number: +61 3 9902 4272
- Email: maxine.bonham@monash.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nut-night glucose response
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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