Clinical trial NCT05913635: Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses
Official title: Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses in Chinese Adults: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Time-Restricted Fasting
Postprandial Blood Glucose
Continuous Glucose Monitoring
Crossover trial
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from fasting to postprandial postprandial blood glucose
timeFrame: 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
measure: Change from fasting to postprandial insulin
timeFrame: 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
measure: Results of continuous glucose monitoring
timeFrame: 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:
measure: Change from fasting to postprandial blood lipids
timeFrame: 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
measure: Analyzes of clock gene expression in peripheral blood cells (PBC)
timeFrame: 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
measure: Analyzes of postprandial plasma metabolome
timeFrame: Blood samples collected at 2 hours after each meal
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Planned Parenthood Research Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Yuwei Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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/ajcn.116.151332. Epub 2017 May 10.
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 Clinical Trial. Diabetes Care. 2017 Nov;40(11):1573-1579. doi: 10.2337/dc16-2753. Epub 2017 Aug 22.
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 Jul 1;110(1):41-52. doi: 10.1093/ajcn/nqy346.
citation: 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.
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.