- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545330
Effect of Circadian Timing of a Standardized Meal on Postprandial Glucose Response in Healthy Adults
April 16, 2026 updated by: King Faisal University
This randomized crossover study aims to investigate the effect of circadian timing of a standardized meal (morning versus evening consumption) on postprandial glucose response in healthy adults.
Postprandial glucose will be assessed using the incremental area under the curve (iAUC) over 120 minutes.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
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
- Name: Wafa Alotaibi, PhD
- Phone Number: +966500358622
- Email: Walotaibi@kfu.edu.sa
Study Locations
-
-
Eastern Province
-
Al-Ahsa, Eastern Province, Saudi Arabia, 31982
- King Faisal University
-
Contact:
- Wafa Alotaibi
- Phone Number: +966500358622
- Email: Walotaibi@kfu.edu.sa
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy adults aged 18 years and older
- Able and willing to provide informed consent
- Able to comply with study procedures
Exclusion Criteria:
- Diagnosis of diabetes or any metabolic disorder affecting glucose regulation
- Use of any medications
- Pregnant or breastfeeding women
- Night shift workers or individuals with irregular sleep patterns
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morning Meal Condition
Participants will consume a standardized test meal in the morning following an overnight fasting period of at least 8 hours.
Postprandial glucose will be measured over 120 minutes.
|
The standardized test meal provided 50 g of carbohydrates of weighed portions of white bread and jam, served with 200 mL of water.
|
|
Experimental: Evening Meal Condition
Participants will consume the same standardized test meal in the evening following a standardized fasting period of at least 8 hours prior to the test meal.
Postprandial glucose will be measured over 120 minutes.
|
The standardized test meal provided 50 g of carbohydrates of weighed portions of white bread and jam, served with 200 mL of water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental Area Under the Curve (iAUC) for Postprandial Glucose
Time Frame: Baseline to 120 minutes after consumption of the standardized test meal
|
The primary objective of this study is to investigate the effect of circadian timing of a standardized test meal (morning versus evening consumption) on postprandial glucose response in healthy adults, assessed as the incremental area under the curve (iAUC) for capillary blood glucose over 120 minutes following meal consumption
|
Baseline to 120 minutes after consumption of the standardized test meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Postprandial Glucose (Morning vs Evening)
Time Frame: Baseline to 120 minutes after consumption of the standardized test meal
|
Peak capillary blood glucose concentration measured within 120 minutes after consumption of the standardized test meal, under morning and evening conditions
|
Baseline to 120 minutes after consumption of the standardized test meal
|
|
Time to Peak Glucose (Morning vs Evening)
Time Frame: Baseline to 120 minutes after consumption of the standardized test meal
|
Time required to reach peak capillary blood glucose concentration following meal consumption, under morning and evening conditions.
|
Baseline to 120 minutes after consumption of the standardized test meal
|
|
Postprandial Glucose Profile (Morning vs Evening)
Time Frame: Baseline, 15, 30, 60, 90, and 120 minutes after consumption of the standardized test meal
|
Capillary blood glucose concentrations measured at predefined time points following consumption of the standardized test meal, under morning and evening conditions.
|
Baseline, 15, 30, 60, 90, and 120 minutes after consumption of the standardized test meal
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Night Eating Behavior
Time Frame: Baseline
|
Night eating behavior will be assessed using the validated Night Eating Questionnaire to characterize nocturnal eating patterns and support interpretation of variability in postprandial glucose responses.
|
Baseline
|
|
Sleep Duration and Quality
Time Frame: Baseline
|
Sleep duration and quality will be assessed using a validated sleep questionnaire administered prior to each study visit to support interpretation of postprandial glucose responses.
|
Baseline
|
|
Chronotype
Time Frame: Baseline
|
Chronotype will be assessed at baseline using the validated Questionnaire to characterize individual circadian preference and support interpretation of postprandial glucose responses.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Estimated)
April 15, 2026
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 16, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- ETHICS3992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified individual participant data (IPD) collected in this study will not be made publicly available.
Data will be used for research purposes by the study investigators only
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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