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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:
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumption of lunch and dinner, with no breakfast | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from fasting to postprandial postprandial blood glucose | The primary endpoint is fasting and postprandial blood glucose with hexokinase tests. | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from fasting to postprandial blood lipids | Fasting and postprandial total-, HDL-, LDL-cholesterol, triglyceride will be tested. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuwei Liu, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Planned Parenthood Research Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28490511 | Result | 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. | |
| 28830875 | Result | Jakubowicz 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. |
| Label | URL |
|---|---|
| Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk | View source |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062409 | Lunch |
| D062407 | Meals |
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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A randomized, crossover study design uses two intervention days (a no-breakfast day and a no-dinner day) and a 6-day washout period.
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The researchers who conducted the biomarker measurements were not aware of the assignments of the trial.
|
| Consumption of breakfast and lunch, with no dinner | Behavioral | 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. |
|
| Analyzes of clock gene expression in peripheral blood cells (PBC) |
Clock gene expression in PBC will be evaluated by RT-PCR. |
| 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. | Blood samples collected at 2 hours after each meal |
| 31095288 | Result | Ogata 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. |
| 35015083 | Result | Garaulet 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. |
| 28455106 | Result | Lopez-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. |
| Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical Trial | View source |
| Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese males | View source |
| Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. | View source |
| Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study. | View source |