Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses

Healthy Clinical Trial

Official title:

Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses in Chinese Adults: A Randomized Crossover Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05913635
• Other study ID #: 21PJD005
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Both men and women are eligible.

2. Age: 18-40 years old.

3. Healthy adults: no history of diabetes mellitus, no use of hypoglycemic drugs, no insulin injection.

4. All participants have a good sleep circle, with no somnipathy.

Exclusion Criteria:

1. Severe mental illness or other major medical comorbidities and autoimmune diseases (e.g., chronic renal failure, cardiovascular diseases, or cancer)

2. Skipping breakfast or dinner more than 10 times within 6 months.

3. Following a special diet, currently on weight loss medication, using sleeping medications.

4. Pregnancy or to be pregnant.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Consumption of lunch and dinner, with no breakfast
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 dinner
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.

Locations

Country	Name	City	State
China	Shanghai Institute of Planned Parenthood Research Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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 R — View Citation

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 — View Citation

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. — View Citation

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/aj — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Secondary	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
Secondary	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
Secondary	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

External Links

•   Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese males
•   Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk
•   Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical Trial
•   Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial.
•   Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study.