Postprandial HyperglycemiaNCT04965896
Nut Intake At Night: Effect on Postprandial Glycaemia
A study testing Nut meal in people with Postprandial Hyperglycemia and Insulin Resistance, run by Monash University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Insulin Resistance
- What is being tested?
- Nut meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postprandial Hyperglycemia, Insulin Resistance
- Being tested
- Control meal, Nut meal
- Keywords
- glucose tolerance, meal timing, insulin, nuts, postprandial
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control mealOther
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.
Nut mealOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nut meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma glucose area under the curve (iAUC)
Difference in postprandial plasma glucose iAUC
Measured: 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
Measured: 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
Difference in postprandial glucose concentration
Measured: 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
Difference in postprandial insulin concentration
Measured: 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
Difference in time to peak glucose
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startDec 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Why it stopped: Trial was planned for 2020, but Melbourne 2020 and 2021 lockdowns hindered the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara R. Cardoso, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965896
- Sponsor's protocol ID
- Nut-night glucose response
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nut Intake At Night on Postprandial Glycaemia: a Randomised Crossover Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT04965896
- Acronym / sponsor ID
- Nut-night glucose response
- Conditions
- Postprandial Hyperglycemia, Insulin Resistance
- Keywords
- glucose tolerance, meal timing, insulin, nuts, postprandial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was planned for 2020, but Melbourne 2020 and 2021 lockdowns hindered the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control meal | Placebo comparator | Other: Control mealParticipants 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. |
| Nut meal | Experimental | Other: Nut mealParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control mealParticipants 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 mealParticipants 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 |
Primary outcome
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
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
3 secondary outcomes
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.
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.
Time to peak glucose
Time frame: Three hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nut meal in people with Postprandial Hyperglycemia and Insulin Resistance, run by Monash University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.