UMIN-ICDS Clinical Trial

Public title

Effects of Regular and Irregular Breakfast Skipping on Vascular Endothelial Function and Glucose/Lipid Metabolism

Acronym

Effect of Breakfast Skipping on Vascular Endothelial Function

Scientific Title

Effects of Regular and Irregular Breakfast Skipping on Vascular Endothelial Function and Glucose/Lipid Metabolism

Scientific Title:Acronym

Effect of Breakfast Skipping on Vascular Endothelial Function

Region

Japan

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Skipping breakfast is considered a risk factor for cardiovascular disease, including atherosclerosis. However, interpretation of these data may be complicated by numerous unmeasured confounding factors. Therefore, it is important to investigate whether breakfast skipping itself has a causal relationship with cardiovascular outcomes, such as vascular endothelial function (VEF), a biomarker of cardiovascular disease. The aim of this study is to examine the effect of breakfast skipping patterns on brachial artery VEF in healthy adult men and women with regular breakfast habits. In addition, the study aims to examine the effects of breakfast skipping on post-ntervention glucose and lipid metabolism in response to meals.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

endothelial function

Key secondary outcomes

Blood glucose, plasma insulin, plasma free fatty acids, plasma triglycerides, plasma ketones, interstitial fluid glucose concentration, blood pressure, heart rate, brachial artery blood flow velocity, brachial artery vessel diameter, step count, sleep time, sublingual body temperature, body weight, body fat mass, body fat percentage, lean body mass, phase angle

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food	Behavior,custom	Other

Interventions/Control_1

Healthy young adults with regular breakfast habits will participate in a total of three experimental protocols (10 days per protocol) in a randomized order. The day before each experiment, participants will consume meals at prescribed times: breakfast (8:00), lunch (12:00), and dinner (19:00). In the Continuous Breakfast Skipping (Skip) condition, participants will consume two meals (lunch and dinner) from Day 1 to Day 8 and all three meals, including breakfast, on Day 9. The skipped breakfast meals in the Skip condition will be evenly distributed between lunch and dinner. Laboratory measurements will be performed on days 1, 2, 5, 8, and 9, with vascular endothelial function (VEF) testing performed on the right brachial artery at 8:00 am. Blood samples are taken from the left hand before breakfast, 30 minutes after breakfast, before lunch, 30 minutes after lunch, and 180 minutes after lunch to measure blood glucose (BG), plasma insulin (PI), plasma free fatty acids (FFA), and plasma triglycerides (TG). To measure and evaluate glucose fluctuations outside the laboratory, interstitial fluid glucose concentration sensors will be placed on the left dorsal upper arm of participants starting 2 days before the experiment and continuous measurements will be taken until 8:00 am on day 10.

Interventions/Control_2

Healthy young adults with regular breakfast habits will participate in a total of three experimental protocols (10 days per protocol) in a random order. On the day before each experiment, participants will consume meals at prescribed times: breakfast (8:00), lunch (12:00), and dinner (19:00).In the Intermittent Breakfast Skipping (Eat/Skip) condition, participants will alternate between consuming and skipping breakfast from day 1 to day 9. The skipped breakfast meals in Eat/Skip condition will be evenly distributed between lunch and dinner. Measurements in the laboratory will be taken on days 1, 2, 5, 8, and 9, with vascular endothelial function (FMD) testing conducted on the right brachial artery at 8:00 AM. Blood samples will be collected from the left hand before breakfast, 30 minutes after breakfast, before lunch, 30 minutes after lunch, and 180 minutes after lunch to measure blood glucose (BG), plasma insulin (PI), plasma free fatty acids (FFA), and plasma triglycerides (TG). To measure and evaluate blood glucose fluctuations outside the laboratory, sensors for interstitial fluid glucose concentration measurement will be attached to the left dorsal upper arm of participants starting 2 days before the experiment, and continuous measurements will be taken until 8:00 AM on day 10.

Interventions/Control_3

Healthy young adults with regular breakfast habits will participate in a total of three experimental protocols (10 days per protocol) in a random order. On the day before each experiment, participants will consume meals at prescribed times: breakfast (8:00), lunch (12:00), and dinner (19:00). In the Breakfast Intake (Eat) condition, participants will consume three meals (breakfast, lunch, and dinner) at the same times from day 1 to day 9 of the experiment. Measurements in the laboratory will be taken on days 1, 2, 5, 8, and 9, with vascular endothelial function (FMD) testing conducted on the right brachial artery at 8:00 AM. Blood samples will be collected from the left hand before breakfast, 30 minutes after breakfast, before lunch, 30 minutes after lunch, and 180 minutes after lunch to measure blood glucose (BG), plasma insulin (PI), plasma free fatty acids (FFA), and plasma triglycerides (TG). To measure and evaluate blood glucose fluctuations outside the laboratory, sensors for interstitial fluid glucose concentration measurement will be attached to the left dorsal upper arm of participants starting 2 days before the experiment, and continuous measurements will be taken until 8:00 AM on day 10.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Age between 20 and 59 years old
2. Not taking any medications and dietary supplements
3. No medical and surgical diseases
4. No smoker
5. A participant who not performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study
6. Must not be the participant of others research within the research period (confirm by asking the participants directly and orally when explaining the research content)
7. A participant who can consume the test meal in the study
8. A participant whose menstrual cycle is normal

Key exclusion criteria

1. Not age between 20 and 59 years old
2. A participant who takes medications and dietary supplements
3. A participant who has medical and surgical diseases
4. Smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study
6. A participant who are scheduled to participate to others research.
7. A participant who cannot consume the test meal in the study
8. A participant who is pregnant, suspected of being pregnant, and within 1 year of parturition

Target sample size

14

Name of lead principal investigator

1st name	Hideaki
Middle name
Last name	Kashima

Organization

Prefectural University of Hiroshima

Division name

Department of Health Sciences

Zip code

734-8558

Address

1-1-71 Ujina-higashi, Minami-ku, Hiroshima

TEL

0822519806

Email

h-kashima@pu-hiroshima.ac.jp

Name of contact person

1st name	Hideaki
Middle name
Last name	Kashima

Organization

Prefectural University of Hiroshima

Division name

Department of Health Sciences

Zip code

7340036

Address

1-1-71 Ujina-higashi, Minami-ku, Hiroshima

TEL

082-251-9806

Homepage URL

Email

h-kashima@pu-hiroshima.ac.jp

Institute

Prefectural University of Hiroshima

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Prefectural University of Hiroshima

Address

1-1-71 Ujina-higashi, Minami-ku, Hiroshima

Tel

0822519534

Email

kikaku2@pu-hiroshima.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

08

Month

04

Day

Date of IRB

2023

Year

08

Month

04

Day

Anticipated trial start date

2023

Year

12

Month

20

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

15

Day

Last modified on

2023

Year

12

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060615