- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795205
Delayed Dinner, Exercise and Glucose Metabolism
April 4, 2023 updated by: Yung-Chih Chen, National Taiwan Normal University
Impact of Exercise on Metabolic Health Following Delayed Dinner Consumption in Healthy Adults
This study aims to investigate whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yung-Chih Chen
- Phone Number: +886277496979
- Email: yc.chen@ntnu.edu.tw
Study Contact Backup
- Name: Chen
- Email: yc.chen@ntnu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan Normal University
-
Contact:
- Yung-Chih Chen, PhD
- Email: yc.chen@ntnu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Physical inactive males
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
- Able to walk comfortably on a treadmill
- Dinner consumers with normal sleep pattern (cycles)
Exclusion Criteria:
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
- Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal dinner consumption
Participants will have their dinner between 1800-1830pm
|
Participants will consume breakfast at 0830-0855 am, lunch at 1230-1255 pm, followed by dinner at 1800-1825 pm.
Snacks will be consumed at 2130-2140 pm.
|
Experimental: Delayed dinner consumption
Participants will have their dinner between 2200-2230pm
|
Participants will consume breakfast at 08:30-08:55 am, lunch at 12:30-12:55 pm, followed by snacks at 18:00-18:10 pm.
Dinner will be consumed at 21:30-21:55 pm.
|
Experimental: Exercise with delayed dinner consumption
Participants will exercise on a treadmill for 45 min followed by delayed dinner between 2200-2230pm
|
Participants will consume breakfast at 08:30-08:55 am, lunch at 12:30-12:55 pm, followed by snacks at 18:00-18:10 pm.
Participants will exercise for 45 min at moderate-intensity 45 min prior to the delayed dinner at 21:30-21:55 pm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic health (Oral glucose tolerance test, OGTT)
Time Frame: 120 minutes
|
Fasting and postprandial blood glucose responses on next morning between trials
|
120 minutes
|
Metabolic health (Oral glucose tolerance test, OGTT)
Time Frame: 120 minutes
|
Fasting and postprandial blood insulin responses on next morning between trials
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammation
Time Frame: Baseline
|
Fasting inflammatory biomarkers (IL-6, TNF-a, CRP) on next morning between trials
|
Baseline
|
Visual analogue scale (VSA)
Time Frame: 120 minutes
|
Changes in VAS from 0-100 mm (e.g., appetite & mood, etc.) on next morning between trials
|
120 minutes
|
Substate oxidation
Time Frame: 120 minutes
|
Lipid and carbohydrate oxidation during OGTT between trials
|
120 minutes
|
Blood pressure
Time Frame: 120 minutes
|
Changes in blood pressure (systolic and diastolic blood pressure) on next morning between trials
|
120 minutes
|
Appetite (lunch intake)
Time Frame: 30 minutes
|
Ab libitum energy intake on next morning by the end of trial
|
30 minutes
|
HRV
Time Frame: Baseline
|
Heart rate variability on next morning between trial
|
Baseline
|
Gut hormones
Time Frame: 120 minutes
|
Changes in blood gut hormones responses on next morning (e.g., GLP-1, PYY and GIP) between trials
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2022
Primary Completion (Anticipated)
August 15, 2023
Study Completion (Anticipated)
August 15, 2023
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202203HM008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal Dinner
-
Umeå UniversityCompletedIdiopathic Normal Pressure Hydrocephalus
-
Uppsala University HospitalUppsala University; Swedish Society for Medical ResearchRecruitingIdiopathic Normal Pressure Hydrocephalus (INPH)Sweden
-
Johns Hopkins UniversityUniversity of Utah; Integra LifeSciences CorporationCompletedIdiopathic Normal Pressure Hydrocephalus (INPH)United States, Canada, Sweden
-
Massachusetts General HospitalRecruitingNormal PhysiologyUnited States
-
National Institute of Environmental Health Sciences...Not yet recruiting
-
National Institute of Neurological Disorders and...RecruitingNormal PhysiologyUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingNormal PregnancyFrance
-
National Institute of Neurological Disorders and...RecruitingNormal PhysiologyUnited States
Clinical Trials on Normal dinner
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Johns Hopkins UniversityUniversity of ArkansasRecruiting
-
Johns Hopkins UniversityCompleted
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompletedObesity | OverweightIran, Islamic Republic of
-
NestléClinical Nutrition Research Centre, SingaporeCompleted
-
Wageningen UniversityZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
The Miriam HospitalBrown University; National Institute of General Medical Sciences (NIGMS)UnknownSleep | Weight Loss | Adolescent Obesity | DietUnited States
-
University of HohenheimCompleted
-
University of AberdeenMaastricht University; University of SurreyCompleted