HealthyNCT05913635
Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses
A study testing Consumption of lunch and dinner, with no breakfast and Consumption of breakfast and lunch, with no dinner in people with Healthy, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate whether fasting timing has a significant effect on postprandial glycemic responses in healthy adults. The main questions it aims to answer are: 1. Whether fasting timing has a significant effect on postprandial insulin actions and plasma glucose concentration. 2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Consumption of lunch and dinner, with no breakfast and Consumption of breakfast and lunch, with no dinner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both men and women are eligible.
- Age: 18-40 years old.
- Healthy adults: no history of diabetes mellitus, no use of hypoglycemic drugs, no insulin injection.
- All participants have a good sleep circle, with no somnipathy.
Who cannot join
- Severe mental illness or other major medical comorbidities and autoimmune diseases (e.g., chronic renal failure, cardiovascular diseases, or cancer)
- Skipping breakfast or dinner more than 10 times within 6 months.
- Following a special diet, currently on weight loss medication, using sleeping medications.
- Pregnancy or to be pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Planned Parenthood Research Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses in Chinese Adults: A Randomized Crossover Study
The goal of this clinical trial is to investigate whether fasting timing has a significant effect on postprandial glycemic responses in healthy adults. The main questions it aims to answer are:
- Whether fasting timing has a significant effect on postprandial insulin actions and plasma glucose concentration.
- Whether fasting timing could modulate the glycemic metabolome and circadian rhythms in healthy individuals.
Participants will get the two interventions:
No-dinner: breakfast at 7.30 a.m., lunch at 1.00 p.m. and no dinner; No-breakfast: no breakfast, lunch at 1.00 p.m. and dinner at 8.00 p.m.
Read the detailed description
A randomized, crossover study design is used with 2 intervention days and a 6-day washout period, to evaluate the effects of early and late fasting on postprandial glucose responses in healthy adults. Randomization was performed by the Fudan staff with a block size of 2 using a balanced design using computer-executed software. The primary endpoint is the fasting and postprandial blood glucose, insulin, and continuous glucose monitoring after fasting. Secondary endpoints include postprandial blood lipids, clock gene expressions in peripheral blood cells, and non-targeted postprandial plasma metabolome. The 2 intervention days include a no-breakfast day and a no-dinner day. The diets before, during, and after the intervention day was designed according to Dietary Guidelines for Chinese Residents (2022), and the energy distribution of three meals is 1:1:1, with the energy percentage of carbohydrate, protein, and fat being 55%, 15%, and 30%, respectively. The time of breakfast, lunch, and dinner is 7.30 a.m., 1.00 p.m., and 8.00 p.m., respectively. All participants are instructed to follow their natural dietary plans in the wash-out period, and the food intakes and sleep circle were recorded by a modified food frequency questionnaire (FFQ).
- Conditions
- Healthy
- Being tested
- Consumption of lunch and dinner, with no breakfast, Consumption of breakfast and lunch, with no dinner
- Keywords
- Time-Restricted Fasting, Postprandial Blood Glucose, Continuous Glucose Monitoring, Crossover trial
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of lunch and dinner, with no breakfastBehavioural
The day before intervention day, all participants will be provided with 3 nutritionally balanced meals which are designed by the investigators. On the no-breakfast intervention day, participants are instructed to fast and only be allowed to consume water until 1.00 p.m. and consume the above-designed lunch and dinner at 1.00 p.m. and 8.00 p.m. Additionally, all participants are informed that they are only allowed to consume water between meals and before receiving breakfast at 7.30 a.m. the following day.
Consumption of breakfast and lunch, with no dinnerBehavioural
The day before intervention day, all participants will be provided with 3 nutritionally balanced meals which are designed by the investigators. On the no-dinner intervention day, participants are instructed to consume the above-designed breakfast and lunch at 7.30 a.m. and 1.00 p.m., and no dinner. Additionally, all participants are informed that they are only allowed to consume water between meals and before receiving breakfast at 7.30 a.m. on the following day.
| Study group | Role | What they receive |
|---|---|---|
| No-breakfast | Experimental | One-day meal plan with no breakfast. The dietary plan has been developed according to the Dietary Guidelines for Chinese Residents (2022), and the energy distribution of the two meals (lunch and dinner) is 1:1, with the energy percentage of carbohydrates, proteins, and fats being 55%, 15%, and 30%, respectively. The total daily calorie intake has been calculated based on the gender difference of the participants. Since the recommended daily calorie intake for males is 2000 kcal while for females it is 1600 kcal, each meal for males is designed to provide 667 kcal calories, comprising 92g carbohydrates, 22g fat, and 25g protein; each meal for females is designed to provide 533 kcal calories, comprising 73g carbohydrates, 18g fat, and 20g protein. The carbohydrates are sourced from buckwheat flour and mixed grain rice, which create similar glycemic indexes for each meal. Additionally, the one-day meal for both males and females includes 450g of vegetables and 320g of fruits. Receives: Behavioral: Consumption of lunch and dinner, with no breakfast |
| No-dinner | Experimental | One-day meal plan with no dinner. The dietary plan has been developed according to the Dietary Guidelines for Chinese Residents (2022), and the energy distribution of the two meals (breakfast and lunch) is 1:1, with the energy percentage of carbohydrates, proteins, and fats being 55%, 15%, and 30%, respectively. The total daily calorie intake has been calculated based on the gender difference of the participants. Since the recommended daily calorie intake for males is 2000 kcal while for females it is 1600 kcal, each meal for males is designed to provide 667 kcal calories, comprising 92g carbohydrates, 22g fat, and 25g protein; each meal for females is designed to provide 533 kcal calories, comprising 73g carbohydrates, 18g fat, and 20g protein. The carbohydrates are sourced from buckwheat flour and mixed grain rice, which create similar glycemic indexes for each meal. Additionally, the one-day meal for both males and females includes 450g of vegetables and 320g of fruits. Receives: Behavioral: Consumption of breakfast and lunch, with no dinner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from fasting to postprandial postprandial blood glucose
The primary endpoint is fasting and postprandial blood glucose with hexokinase tests.
Measured: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Change from fasting to postprandial insulin
Fasting and postprandial insulin will be tested by ELISA KIT.
Measured: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Results of continuous glucose monitoring
Continuous glucose will be monitored by Abott glucose monitor.
Measured: From the day before the first intervention day and the wash-out period till the day after the second intervention day (10 days in total)
Secondary outcomes (3)
Change from fasting to postprandial blood lipids
Fasting and postprandial total-, HDL-, LDL-cholesterol, triglyceride will be tested.
Measured: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Analyzes of clock gene expression in peripheral blood cells (PBC)
Clock gene expression in PBC will be evaluated by RT-PCR.
Measured: PBC samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Analyzes of postprandial plasma metabolome
Non-targeted plasma metabolites will be tested by LC-MS-MS after 2 hours of each meal.
Measured: Blood samples collected at 2 hours after each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2022
- Primary completion25 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, crossover study design uses two intervention days (a no-breakfast day and a no-dinner day) and a 6-day washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuwei Liu, Fudan University
- Investigators
- Yuwei Liu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913635
- Sponsor's protocol ID
- 21PJD005
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.
PubMed 28490511Jakubowicz D, Wainstein J, Landau Z, Raz I, Ahren B, Chapnik N, Ganz T, Menaged M, Barnea M, Bar-Dayan Y, Froy O. Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2017 Nov;40(11):1573-1579. doi: 10.2337/dc16-2753. Epub 2017 Aug 22.
PubMed 28830875Ogata H, Kayaba M, Tanaka Y, Yajima K, Iwayama K, Ando A, Park I, Kiyono K, Omi N, Satoh M, Tokuyama K. Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese males. Am J Clin Nutr. 2019 Jul 1;110(1):41-52. doi: 10.1093/ajcn/nqy346.
PubMed 31095288Garaulet M, Lopez-Minguez J, Dashti HS, Vetter C, Hernandez-Martinez AM, Perez-Ayala M, Baraza JC, Wang W, Florez JC, Scheer FAJL, Saxena R. Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. Diabetes Care. 2022 Mar 1;45(3):512-519. doi: 10.2337/dc21-1314.
PubMed 35015083Lopez-Minguez J, Saxena R, Bandin C, Scheer FA, Garaulet M. Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study. Clin Nutr. 2018 Aug;37(4):1133-1140. doi: 10.1016/j.clnu.2017.04.003. Epub 2017 Apr 10.
PubMed 28455106
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses in Chinese Adults: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT05913635
- Acronym / sponsor ID
- 21PJD005
- Conditions
- Healthy
- Keywords
- Time-Restricted Fasting, Postprandial Blood Glucose, Continuous Glucose Monitoring, Crossover trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jun 2023 (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 goal of this clinical trial is to investigate whether fasting timing has a significant effect on postprandial glycemic responses in healthy adults. The main questions it aims to answer are:
- Whether fasting timing has a significant effect on postprandial insulin actions and plasma glucose concentration.
- Whether fasting timing could modulate the glycemic metabolome and circadian rhythms in healthy individuals.
Participants will get the two interventions:
No-dinner: breakfast at 7.30 a.m., lunch at 1.00 p.m. and no dinner; No-breakfast: no breakfast, lunch at 1.00 p.m. and dinner at 8.00 p.m.
Detailed description
A randomized, crossover study design is used with 2 intervention days and a 6-day washout period, to evaluate the effects of early and late fasting on postprandial glucose responses in healthy adults. Randomization was performed by the Fudan staff with a block size of 2 using a balanced design using computer-executed software. The primary endpoint is the fasting and postprandial blood glucose, insulin, and continuous glucose monitoring after fasting. Secondary endpoints include postprandial blood lipids, clock gene expressions in peripheral blood cells, and non-targeted postprandial plasma metabolome. The 2 intervention days include a no-breakfast day and a no-dinner day. The diets before, during, and after the intervention day was designed according to Dietary Guidelines for Chinese Residents (2022), and the energy distribution of three meals is 1:1:1, with the energy percentage of carbohydrate, protein, and fat being 55%, 15%, and 30%, respectively. The time of breakfast, lunch, and dinner is 7.30 a.m., 1.00 p.m., and 8.00 p.m., respectively. All participants are instructed to follow their natural dietary plans in the wash-out period, and the food intakes and sleep circle were recorded by a modified food frequency questionnaire (FFQ).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, crossover study design uses two intervention days (a no-breakfast day and a no-dinner day) and a 6-day washout period.
| Arm | Type | Receives |
|---|---|---|
| No-breakfast | Experimental | Behavioral: Consumption of lunch and dinner, with no breakfastOne-day meal plan with no breakfast. The dietary plan has been developed according to the Dietary Guidelines for Chinese Residents (2022), and the energy distribution of the two meals (lunch and dinner) is 1:1, with the energy percentage of carbohydrates, proteins, and fats being 55%, 15%, and 30%, respectively. The total daily calorie intake has been calculated based on the gender difference of the participants. Since the recommended daily calorie intake for males is 2000 kcal while for females it is 1600 kcal, each meal for males is designed to provide 667 kcal calories, comprising 92g carbohydrates, 22g fat, and 25g protein; each meal for females is designed to provide 533 kcal calories, comprising 73g carbohydrates, 18g fat, and 20g protein. The carbohydrates are sourced from buckwheat flour and mixed grain rice, which create similar glycemic indexes for each meal. Additionally, the one-day meal for both males and females includes 450g of vegetables and 320g of fruits. |
| No-dinner | Experimental | Behavioral: Consumption of breakfast and lunch, with no dinnerOne-day meal plan with no dinner. The dietary plan has been developed according to the Dietary Guidelines for Chinese Residents (2022), and the energy distribution of the two meals (breakfast and lunch) is 1:1, with the energy percentage of carbohydrates, proteins, and fats being 55%, 15%, and 30%, respectively. The total daily calorie intake has been calculated based on the gender difference of the participants. Since the recommended daily calorie intake for males is 2000 kcal while for females it is 1600 kcal, each meal for males is designed to provide 667 kcal calories, comprising 92g carbohydrates, 22g fat, and 25g protein; each meal for females is designed to provide 533 kcal calories, comprising 73g carbohydrates, 18g fat, and 20g protein. The carbohydrates are sourced from buckwheat flour and mixed grain rice, which create similar glycemic indexes for each meal. Additionally, the one-day meal for both males and females includes 450g of vegetables and 320g of fruits. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both men and women are eligible.
- Age: 18-40 years old.
- Healthy adults: no history of diabetes mellitus, no use of hypoglycemic drugs, no insulin injection.
- All participants have a good sleep circle, with no somnipathy.
Key exclusion criteria (4 listed)
- Severe mental illness or other major medical comorbidities and autoimmune diseases (e.g., chronic renal failure, cardiovascular diseases, or cancer)
- Skipping breakfast or dinner more than 10 times within 6 months.
- Following a special diet, currently on weight loss medication, using sleeping medications.
- Pregnancy or to be pregnant.
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 |
|---|---|---|
| Consumption of lunch and dinner, with no breakfastThe day before intervention day, all participants will be provided with 3 nutritionally balanced meals which are designed by the investigators. On the no-breakfast intervention day, participants are instructed to fast and only be allowed to consume water until 1.00 p.m. and consume the above-designed lunch and dinner at 1.00 p.m. and 8.00 p.m. Additionally, all participants are informed that they are only allowed to consume water between meals and before receiving breakfast at 7.30 a.m. the following day. | Behavioural | No-breakfast |
| Consumption of breakfast and lunch, with no dinnerThe day before intervention day, all participants will be provided with 3 nutritionally balanced meals which are designed by the investigators. On the no-dinner intervention day, participants are instructed to consume the above-designed breakfast and lunch at 7.30 a.m. and 1.00 p.m., and no dinner. Additionally, all participants are informed that they are only allowed to consume water between meals and before receiving breakfast at 7.30 a.m. on the following day. | Behavioural | No-dinner |
Primary outcome
Change from fasting to postprandial postprandial blood glucose
Time frame: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
The primary endpoint is fasting and postprandial blood glucose with hexokinase tests.
Change from fasting to postprandial insulin
Time frame: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Fasting and postprandial insulin will be tested by ELISA KIT.
Results of continuous glucose monitoring
Time frame: From the day before the first intervention day and the wash-out period till the day after the second intervention day (10 days in total)
Continuous glucose will be monitored by Abott glucose monitor.
3 secondary outcomes
Change from fasting to postprandial blood lipids
Time frame: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Analyzes of clock gene expression in peripheral blood cells (PBC)
Time frame: PBC samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day
Analyzes of postprandial plasma metabolome
Time frame: Blood samples collected at 2 hours after each meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 28490511Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.
- Results publication: PubMed 28830875Jakubowicz D, Wainstein J, Landau Z, Raz I, Ahren B, Chapnik N, Ganz T, Menaged M, Barnea M, Bar-Dayan Y, Froy O. Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2017 Nov;40(11):1573-1579. doi: 10.2337/dc16-2753. Epub 2017 Aug 22.
- Results publication: PubMed 31095288Ogata H, Kayaba M, Tanaka Y, Yajima K, Iwayama K, Ando A, Park I, Kiyono K, Omi N, Satoh M, Tokuyama K. Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese males. Am J Clin Nutr. 2019 Jul 1;110(1):41-52. doi: 10.1093/ajcn/nqy346.
- Results publication: PubMed 35015083Garaulet M, Lopez-Minguez J, Dashti HS, Vetter C, Hernandez-Martinez AM, Perez-Ayala M, Baraza JC, Wang W, Florez JC, Scheer FAJL, Saxena R. Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. Diabetes Care. 2022 Mar 1;45(3):512-519. doi: 10.2337/dc21-1314.
- Results publication: PubMed 28455106Lopez-Minguez J, Saxena R, Bandin C, Scheer FA, Garaulet M. Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study. Clin Nutr. 2018 Aug;37(4):1133-1140. doi: 10.1016/j.clnu.2017.04.003. Epub 2017 Apr 10.
- Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic riskLink provided by the sponsor.
- Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical TrialLink provided by the sponsor.
- Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese malesLink provided by the sponsor.
- Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial.Link provided by the sponsor.
- Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Yuwei Liu, PhD principal investigator
Fudan 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 Consumption of lunch and dinner, with no breakfast and Consumption of breakfast and lunch, with no dinner in people with Healthy, run by Fudan University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 China. 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?
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 from fasting to postprandial postprandial blood glucose (time frame: Blood samples collected before and after 2 hours at lunch on the no-breakfast day; blood samples collected before and after 2 hours at next day breakfast on the no-dinner day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913635, which also lists 5 linked publications.
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 Jun 2023.