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NCT Number: NCT07447505

Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Faisal University

Al-Ahsa, Eastern Province, 31982, Saudi Arabia

Location status: Recruiting

Location contact

Wafa Alotaibi, PhD

CONTACT

[email protected]

+966135897656

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years and older
  • Willingness to comply with study procedures, including fasting and continuous glucose monitoring
  • Ability to provide informed consent

Exclusion criteria

  • 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)

Treatment and study plan

High-Protein, High-Fiber Meal

Other

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 Meal

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours.

  2. Post-Meal CGM Glucose Response

    Time frame: 0-120 minutes after the pre-fast meal during each intervention condition.

    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).

Other outcomes

  1. Association Between Glucose and Appetite (Exploratory)

    Time frame: Assessed on Day 1 and Day 2 of each intervention period at the predefined appetite assessment time points: baseline prior to the pre-fast meal, 30 minutes post-meal, 60 minutes post-meal, 4:00 PM, and 30 minutes prior to breaking the fast.

    CGM Glucose Concentration and Subjective Appetite Ratings at Predefined Time Points

Study contacts

Contact information is provided by the study sponsor or research team.

Wafa Alotaibi

CONTACT

[email protected]

+966500358622

Sponsors and collaborators

Lead sponsor

King Faisal University

Other

Collaborators

  • Saudi Food and Drug Authority

Registry information

Official study title

Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study

Acronym: FAST-SAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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