PreDiabetesNCT05413928
Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
A study testing Time Restrictive Eating- late, Time Restrictive Eating- early and Time Restrictive Eating- early with early caloric intake in people with PreDiabetes and Type 2 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Type 2 Diabetes, Healthy
- What is being tested?
- Time Restrictive Eating- late, Time Restrictive Eating- early and Time Restrictive Eating- early with early caloric intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 28 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older;
- Not be pregnant, if female;
- Be generally healthy (with no apparent symptoms at the time of enrollment)
- Patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
- Be willing to provide written informed consent for all study procedures.
Who cannot join
- major organ disease
- pregnant/lactating
- diabetes medications except for metformin
- malabsorptive disorders like celiac sprue
- heavy alcohol use
- use of weight loss medications or specific diets
Show all 10Show fewer
- weight change >2 Kg in the last month
- history of bariatric surgery
- Any medical condition that physicians believe would interfere with study participation or evaluation of results
- Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.
Read the detailed description
Pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. The investigators are interested in understanding the effect of caloric distribution through the day, specifically consuming more later in the day versus earlier in the day. The investigators want to test the hypothesis that consolidating the meals during a shorter span in the day (time restricted eating) can ameliorate blood sugars and sleep parameters in the studied population. The researchers would also like to compare dynamic range of meal-induced sympathetic responses (e.g. temperature and heart rate changes) between different metabolic health conditions (e.g. insulin sensitive vs insulin resistant vs diabetes) while controlling for dietary intake. Previous research studies suggest that people with different metabolic health conditions would have different meal-induced sympathetic responses. Based on this, the primary goal of the study is to characterize metabolic health based on non-invasive wearable sensor data that measure these responses.
- Conditions
- PreDiabetes, Type 2 Diabetes, Healthy
- Being tested
- Time Restrictive Eating- late, Time Restrictive Eating- early, Time Restrictive Eating- early with early caloric intake, Macronutrient-controlled meals
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restrictive Eating- lateBehavioural
Eating window will be 10 hours or less, starting 3 hours after waking up. Same monitoring as Baseline phase.
Time Restrictive Eating- earlyBehavioural
Eating window will be 10 hours or less, starting 30 min after waking up. Same monitoring as Baseline phase.
Time Restrictive Eating- early with early caloric intakeBehavioural
Same as TRE-early, but concentrating caloric intake early in the eating window Same monitoring as Baseline phase.
Macronutrient-controlled mealsOther
Meals with a determined amount of protein, carbohydrates, and fat.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping). Receives: Behavioral: Time Restrictive Eating- late; Behavioral: Time Restrictive Eating- early; Behavioral: Time Restrictive Eating- early with early caloric intake; Other: Macronutrient-controlled meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control as measured by change in blood sugar values.
Change in glycemic control measured from baseline through all phases of study. Glycemic control is derived from continuous glucose monitor (CGM) data and expressed in milligrams/deciliter
Measured: 5 months
Core body temperature response to meal consumption
Analysis of core body temperature response as measured by change from overnight fasting condition to the peak value within 4 hrs following the standardized meal consumption. Core body temperature response is derived from CTM data and expressed in Celsius.
Measured: Analysis of response to all standard meals will take 9 days
Secondary outcomes (6)
Change in sleep quality measured as duration of sleep stages
Duration of each sleep stage (i.e. light, deep, REM, wake stages) overnight. Sleep quality will be measured via a headband wearable device. Sleep quality will be compared to baseline through the other intervention phases.
Measured: 5 months
Change in sleep quality measured as frequency of sleep stages
Frequency of each sleep stage (i.e. light, deep, REM, wake stages) overnight. Sleep quality will be measured via a headband wearable device. Sleep quality will be compared to baseline through the other intervention phases.
Measured: 5 months
Change in wake duration during sleep
Measurement of Wake After Sleep Onset (WASO) in minutes. Measured via a headband wearable device. WASO will be compared to baseline through the other intervention phases.
Measured: 5 months
Sleep efficiency
Sleep efficiency will be calculated by the following formula: 100-((WASO/total sleep duration)x100).
Changes will be compared from baseline to the rest of the intervention phases.
Measured: 5 months
Sleep latency
Sleep latency is the duration in minutes from being awake to falling asleep. Changes in sleep latency will be compared from baseline to the rest of the intervention phases.
Measured: 5 months
Heart rate response to meal consumption
Heart rate response to meal consumption as measured by the change in heart rate from baseline (overnight fasting condition) to the peak value within 4 hrs following the standardized meal consumption. Heart rate response is derived from continuous heart rate monitoring (CHRM) data and expressed in beats per minute (bpm).
Measured: Analysis of response to all standard meals will take 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Feb 2023
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Why it stopped: The study was stopped due to insufficient dietary differences, loss of support for the sleep device after acquisition, and high variability in temperature data, all these prevented meaningful evaluation of study aims.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Wu, Stanford University
- Investigators
- Michael Snyder, PhD, Principal investigator, Stanford UniversityYue Wu, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413928
- Sponsor's protocol ID
- 61843
- Status last verified
- Apr 2026
- First submitted
- 9 May 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
- ClinicalTrials.gov ID
- NCT05413928
- Acronym / sponsor ID
- 61843
- Conditions
- PreDiabetes, Type 2 Diabetes, Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to insufficient dietary differences, loss of support for the sleep device after acquisition, and high variability in temperature data, all these prevented meaningful evaluation of study aims.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 10 Jun 2022 (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.
The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.
Detailed description
Pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. The investigators are interested in understanding the effect of caloric distribution through the day, specifically consuming more later in the day versus earlier in the day. The investigators want to test the hypothesis that consolidating the meals during a shorter span in the day (time restricted eating) can ameliorate blood sugars and sleep parameters in the studied population. The researchers would also like to compare dynamic range of meal-induced sympathetic responses (e.g. temperature and heart rate changes) between different metabolic health conditions (e.g. insulin sensitive vs insulin resistant vs diabetes) while controlling for dietary intake. Previous research studies suggest that people with different metabolic health conditions would have different meal-induced sympathetic responses. Based on this, the primary goal of the study is to characterize metabolic health based on non-invasive wearable sensor data that measure these responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Time Restrictive Eating- late, Behavioral: Time Restrictive Eating- early, Behavioral: Time Restrictive Eating- early with early caloric intake, Other: Macronutrient-controlled mealsParticipants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older;
- Not be pregnant, if female;
- Be generally healthy (with no apparent symptoms at the time of enrollment)
- Patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
- Be willing to provide written informed consent for all study procedures.
Key exclusion criteria (10 listed)
- major organ disease
- pregnant/lactating
- diabetes medications except for metformin
- malabsorptive disorders like celiac sprue
- heavy alcohol use
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 |
|---|---|---|
| Time Restrictive Eating- lateEating window will be 10 hours or less, starting 3 hours after waking up. Same monitoring as Baseline phase. | Behavioural | Intervention |
| Time Restrictive Eating- earlyEating window will be 10 hours or less, starting 30 min after waking up. Same monitoring as Baseline phase. | Behavioural | Intervention |
| Time Restrictive Eating- early with early caloric intakeSame as TRE-early, but concentrating caloric intake early in the eating window Same monitoring as Baseline phase. | Behavioural | Intervention |
| Macronutrient-controlled mealsMeals with a determined amount of protein, carbohydrates, and fat. | Other | Intervention |
Primary outcome
Change in glycemic control as measured by change in blood sugar values.
Time frame: 5 months
Change in glycemic control measured from baseline through all phases of study. Glycemic control is derived from continuous glucose monitor (CGM) data and expressed in milligrams/deciliter
Core body temperature response to meal consumption
Time frame: Analysis of response to all standard meals will take 9 days
Analysis of core body temperature response as measured by change from overnight fasting condition to the peak value within 4 hrs following the standardized meal consumption. Core body temperature response is derived from CTM data and expressed in Celsius.
6 secondary outcomes
Change in sleep quality measured as duration of sleep stages
Time frame: 5 months
Change in sleep quality measured as frequency of sleep stages
Time frame: 5 months
Change in wake duration during sleep
Time frame: 5 months
Sleep efficiency
Time frame: 5 months
Sleep latency
Time frame: 5 months
Heart rate response to meal consumption
Time frame: Analysis of response to all standard meals will take 9 days
Results and safety
The study was stopped early (reason given: The study was stopped due to insufficient dietary differences, loss of support for the sleep device after acquisition, and high variability in temperature data, all these prevented meaningful evaluation of study aims.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
Michael Snyder, PhD principal investigator
Stanford University
Yue Wu study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restrictive Eating- late, Time Restrictive Eating- early and Time Restrictive Eating- early with early caloric intake in people with PreDiabetes and Type 2 Diabetes, run by Stanford University at 1 site in United States.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Apr 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 United States. 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?
The study was stopped early (reason given: The study was stopped due to insufficient dietary differences, loss of support for the sleep device after acquisition, and high variability in temperature data, all these prevented meaningful evaluation of study aims.). Results are not available in the source record.
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?
Change in glycemic control as measured by change in blood sugar values. (time frame: 5 months). 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 24 Apr 2026.