Glycemic Response; SatietyFAST-SATNCT07447505
Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting
A study testing High-Protein, High-Fiber Meal and Low-Protein, Low-Fiber Meal in people with Glycemic Response; Satiety and Fasting, Time Restricted, run by King Faisal University at 1 site in Saudi Arabia.
Trial summary
This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response; Satiety, Fasting, Time Restricted, Dietary Intervention
- What is being tested?
- High-Protein, High-Fiber Meal and Low-Protein, Low-Fiber Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Feb 2026to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Willingness to comply with study procedures, including fasting and continuous glucose monitoring
- Ability to provide informed consent
Who cannot join
- Diagnosed diabetes mellitus or known metabolic disease
- History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes
- Use of medications known to affect glucose metabolism or appetite
- Pregnancy or lactation
- Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal University
Al-Ahsa, Eastern Province, 31982
Wafa Alotaibi, PhD, +966135897656, Walotaibi@kfu.edu.sa
About this study
Official title: Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study
This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Participants will complete two dietary conditions in a randomized order: a standardized high-protein, high-fiber pre-fast meal and a low-protein, low-fiber pre-fast meal guided by dietary instructions. Each condition will be followed for two consecutive days and separated by a three-day washout period. Outcomes include subjective appetite sensations during fasting hours, glycemic profiles assessed using continuous glucose monitoring (CGM), and exploratory analyses examining the association between glucose dynamics and appetite sensations.
Read the detailed description
This study is a randomized crossover interventional trial conducted in healthy adults to evaluate the effect of a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours.
Each participant will complete two study conditions in a randomized sequence: a high-protein, high-fiber pre-fast meal condition and a low-protein, low-fiber pre-fast meal condition. Each condition will be followed for two consecutive days and separated by a three-day washout period to minimize potential carryover effects.
During the high-protein, high-fiber condition, participants will consume a standardized pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g). Meals will be provided in pre-measured portions by the research team.
During the low-protein, low-fiber condition, participants will receive standardized written dietary instructions, including a list of foods to avoid, to guide consumption of a low-protein, low-fiber pre-fast meal. No calorie restriction will be applied in either study condition.
Subjective appetite sensations, including hunger, fullness, desire to eat, and prospective food consumption, will be assessed using visual analogue-type scales at predefined time points across the fasting day. Glycemic profiles will be continuously assessed using continuous glucose monitoring (CGM).
Exploratory analyses will examine temporal associations between CGM-derived glucose levels and glucose trends and subjective appetite sensations across the study day.
- Conditions
- Glycemic Response; Satiety, Fasting, Time Restricted, Dietary Intervention, Postprandial Glucose
- Being tested
- High-Protein, High-Fiber Meal, Low-Protein, Low-Fiber Meal
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Protein, High-Fiber MealOther
Participants consume a standardized high-protein, high-fiber pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g) for two consecutive days.
Low-Protein, Low-Fiber MealOther
Participants follow standardized written dietary instructions, including a list of foods to avoid, to consume a low-protein, low-fiber pre-fast meal for two consecutive days. No calorie restriction is applied.
| Study group | Role | What they receive |
|---|---|---|
| High-Protein, High-Fiber Pre-Fast Meal | Experimental | Participants consume a standardized high-protein, high-fiber pre-fast meal for two consecutive days. Receives: Other: High-Protein, High-Fiber Meal |
| Low-Protein, Low-Fiber Pre-Fast Meal | Active comparator | Participants follow standardized written dietary instructions to consume a low-protein, low-fiber pre-fast meal for two consecutive days. Receives: Other: Low-Protein, Low-Fiber Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Satiety During Fasting Hours
Subjective appetite sensations including hunger, fullness, desire to eat, and prospective food consumption assessed using a visual analogue-type scale with numeric anchors ranging from 0 to 10.
Measured: Assessed at baseline prior to the pre-fast meal, 30 and 60 minutes post-meal, mid-afternoon (approximately 4:00 PM), and 30 minutes prior to breaking the fast during each intervention condition.
Secondary outcomes (2)
Glycemic Profiles During Fasting (CGM)
Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours.
Measured: Assessed on Day 1 and Day 2 of each intervention period during the fasting window from completion of the pre-fast meal until breaking the fast.
Post-Meal CGM Glucose Response
Continuous glucose monitoring-derived glucose response in the 0-120 minutes following consumption of the pre-fast meal, including peak glucose and incremental area under the curve (iAUC).
Measured: 0-120 minutes after the pre-fast meal during each intervention condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start23 Feb 2026
- Primary completion23 Mar 2026 (estimated)
- Study completion23 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Response; SatietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- Saudi Food and Drug Authority
- Responsible party
- Principal investigator, Wafa Alotaibi, King Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447505
- Sponsor's protocol ID
- KFU-2026-ETHICS3958
- Acronym
- FAST-SAT
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07447505
- Acronym / sponsor ID
- FAST-SAT / KFU-2026-ETHICS3958
- Conditions
- Glycemic Response; Satiety, Fasting, Time Restricted, Dietary Intervention, Postprandial Glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Collaborators
- Saudi Food and Drug Authority
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 23 Mar 2026 (estimated)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Participants will complete two dietary conditions in a randomized order: a standardized high-protein, high-fiber pre-fast meal and a low-protein, low-fiber pre-fast meal guided by dietary instructions. Each condition will be followed for two consecutive days and separated by a three-day washout period. Outcomes include subjective appetite sensations during fasting hours, glycemic profiles assessed using continuous glucose monitoring (CGM), and exploratory analyses examining the association between glucose dynamics and appetite sensations.
Detailed description
This study is a randomized crossover interventional trial conducted in healthy adults to evaluate the effect of a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours.
Each participant will complete two study conditions in a randomized sequence: a high-protein, high-fiber pre-fast meal condition and a low-protein, low-fiber pre-fast meal condition. Each condition will be followed for two consecutive days and separated by a three-day washout period to minimize potential carryover effects.
During the high-protein, high-fiber condition, participants will consume a standardized pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g). Meals will be provided in pre-measured portions by the research team.
During the low-protein, low-fiber condition, participants will receive standardized written dietary instructions, including a list of foods to avoid, to guide consumption of a low-protein, low-fiber pre-fast meal. No calorie restriction will be applied in either study condition.
Subjective appetite sensations, including hunger, fullness, desire to eat, and prospective food consumption, will be assessed using visual analogue-type scales at predefined time points across the fasting day. Glycemic profiles will be continuously assessed using continuous glucose monitoring (CGM).
Exploratory analyses will examine temporal associations between CGM-derived glucose levels and glucose trends and subjective appetite sensations across the study day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Protein, High-Fiber Pre-Fast Meal | Experimental | Other: High-Protein, High-Fiber MealParticipants consume a standardized high-protein, high-fiber pre-fast meal for two consecutive days. |
| Low-Protein, Low-Fiber Pre-Fast Meal | Active comparator | Other: Low-Protein, Low-Fiber MealParticipants follow standardized written dietary instructions to consume a low-protein, low-fiber pre-fast meal for two consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- Willingness to comply with study procedures, including fasting and continuous glucose monitoring
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Diagnosed diabetes mellitus or known metabolic disease
- History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes
- Use of medications known to affect glucose metabolism or appetite
- Pregnancy or lactation
- Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)
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 |
|---|---|---|
| High-Protein, High-Fiber MealParticipants consume a standardized high-protein, high-fiber pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g) for two consecutive days. | Other | High-Protein, High-Fiber Pre-Fast Meal |
| Low-Protein, Low-Fiber MealParticipants follow standardized written dietary instructions, including a list of foods to avoid, to consume a low-protein, low-fiber pre-fast meal for two consecutive days. No calorie restriction is applied. | Other | Low-Protein, Low-Fiber Pre-Fast Meal |
Primary outcome
Daytime Satiety During Fasting Hours
Time frame: Assessed at baseline prior to the pre-fast meal, 30 and 60 minutes post-meal, mid-afternoon (approximately 4:00 PM), and 30 minutes prior to breaking the fast during each intervention condition.
Subjective appetite sensations including hunger, fullness, desire to eat, and prospective food consumption assessed using a visual analogue-type scale with numeric anchors ranging from 0 to 10.
2 secondary outcomes
Glycemic Profiles During Fasting (CGM)
Time frame: Assessed on Day 1 and Day 2 of each intervention period during the fasting window from completion of the pre-fast meal until breaking the fast.
Post-Meal CGM Glucose Response
Time frame: 0-120 minutes after the pre-fast meal during each intervention condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No. 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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Protein, High-Fiber Meal and Low-Protein, Low-Fiber Meal in people with Glycemic Response; Satiety and Fasting, Time Restricted, run by King Faisal University at 1 site in Saudi Arabia.
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 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wafa Alotaibi (+966500358622, Walotaibi@kfu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Satiety During Fasting Hours (time frame: Assessed at baseline prior to the pre-fast meal, 30 and 60 minutes post-meal, mid-afternoon (approximately 4:00 PM), and 30 minutes prior to breaking the fast during each intervention condition.). 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 12 Mar 2026.