Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses

NCT05913635 | Unknown

• 1 other identifier: 21PJD005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Whether fasting timing has a significant effect on postprandial insulin actions and plasma glucose concentration.
2. 2.Whether fasting timing could modulate the glycemic metabolome and circadian rhythms in healthy individuals.

Conditions

Healthy

Keywords

Time-Restricted Fasting; Postprandial Blood Glucose; Continuous Glucose Monitoring; Crossover trial

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Change from fasting to postprandial blood lipids

  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)

  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

  Blood samples collected at 2 hours after each meal

Study Arms (2)

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.

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.

Behavioral: Consumption of breakfast and lunch, with no dinner

Interventions

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.

No-breakfast

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.

No-dinner

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Institute of Planned Parenthood Research Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (5)

• 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.

  PMID: 28490511 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.

  PMID: 28830875 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.

  PMID: 31095288 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.

  PMID: 35015083 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.

  PMID: 28455106 RESULT

Related Links

• 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
• Effect of skipping breakfast for 6 days on energy metabolism and diurnal rhythm of blood glucose in young healthy Japanese males
• 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.

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Lunch; Meals; Breakfast

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yuwei Liu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who conducted the biomarker measurements were not aware of the assignments of the trial.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized, crossover study design uses two intervention days (a no-breakfast day and a no-dinner day) and a 6-day washout period.

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 22, 2023
• Study Start: September 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)