Normal DinnerNCT05795205
Delayed Dinner, Exercise and Glucose Metabolism
A study testing Normal dinner, Delayed dinner consumption and Exercise with delayed dinner consumption in people with Normal Dinner and Delayed Dinner, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This study aims to investigate whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Dinner, Delayed Dinner, Exercise Plus Delayed Dinner
- What is being tested?
- Normal dinner, Delayed dinner consumption and Exercise with delayed dinner consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Chen contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Normal University
Taipei
Yung-Chih Chen, PhD, yc.chen@ntnu.edu.tw
About this study
Official title: 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
- Conditions
- Normal Dinner, Delayed Dinner, Exercise Plus Delayed Dinner
- Being tested
- Normal dinner, Delayed dinner consumption, Exercise with delayed dinner consumption
- Keywords
- late dinner, postprandial Glycaemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dinnerBehavioural
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.
Delayed dinner consumptionBehavioural
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.
Exercise with delayed dinner consumptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal dinner consumption | Experimental | Participants will have their dinner between 1800-1830pm Receives: Behavioral: Normal dinner |
| Delayed dinner consumption | Experimental | Participants will have their dinner between 2200-2230pm Receives: Behavioral: Delayed dinner consumption |
| Exercise with delayed dinner consumption | Experimental | Participants will exercise on a treadmill for 45 min followed by delayed dinner between 2200-2230pm Receives: Behavioral: Exercise with delayed dinner consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic health (Oral glucose tolerance test, OGTT)
Fasting and postprandial blood glucose responses on next morning between trials
Measured: 120 minutes
Metabolic health (Oral glucose tolerance test, OGTT)
Fasting and postprandial blood insulin responses on next morning between trials
Measured: 120 minutes
Secondary outcomes (7)
Inflammation
Fasting inflammatory biomarkers (IL-6, TNF-a, CRP) on next morning between trials
Measured: Baseline
Visual analogue scale (VSA)
Changes in VAS from 0-100 mm (e.g., appetite \& mood, etc.) on next morning between trials
Measured: 120 minutes
Substate oxidation
Lipid and carbohydrate oxidation during OGTT between trials
Measured: 120 minutes
Blood pressure
Changes in blood pressure (systolic and diastolic blood pressure) on next morning between trials
Measured: 120 minutes
Appetite (lunch intake)
Ab libitum energy intake on next morning by the end of trial
Measured: 30 minutes
HRV
Heart rate variability on next morning between trial
Measured: Baseline
Gut hormones
Changes in blood gut hormones responses on next morning (e.g., GLP-1, PYY and GIP) between trials
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Apr 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal DinnerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Chih Chen, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795205
- Sponsor's protocol ID
- 202203HM008
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Metabolic Health Following Delayed Dinner Consumption in Healthy Adults
- ClinicalTrials.gov ID
- NCT05795205
- Acronym / sponsor ID
- 202203HM008
- Conditions
- Normal Dinner, Delayed Dinner, Exercise Plus Delayed Dinner
- Keywords
- late dinner, postprandial Glycaemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal dinner consumption | Experimental | Behavioral: Normal dinnerParticipants will have their dinner between 1800-1830pm |
| Delayed dinner consumption | Experimental | Behavioral: Delayed dinner consumptionParticipants will have their dinner between 2200-2230pm |
| Exercise with delayed dinner consumption | Experimental | Behavioral: Exercise with delayed dinner consumptionParticipants will exercise on a treadmill for 45 min followed by delayed dinner between 2200-2230pm |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dinnerParticipants 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. | Behavioural | Normal dinner consumption |
| Delayed dinner consumptionParticipants 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. | Behavioural | Delayed dinner consumption |
| Exercise with delayed dinner consumptionParticipants 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. | Behavioural | Exercise with delayed dinner consumption |
Primary outcome
Metabolic health (Oral glucose tolerance test, OGTT)
Time frame: 120 minutes
Fasting and postprandial blood glucose responses on next morning between trials
Metabolic health (Oral glucose tolerance test, OGTT)
Time frame: 120 minutes
Fasting and postprandial blood insulin responses on next morning between trials
7 secondary outcomes
Inflammation
Time frame: Baseline
Visual analogue scale (VSA)
Time frame: 120 minutes
Substate oxidation
Time frame: 120 minutes
Blood pressure
Time frame: 120 minutes
Appetite (lunch intake)
Time frame: 30 minutes
HRV
Time frame: Baseline
Gut hormones
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal dinner, Delayed dinner consumption and Exercise with delayed dinner consumption in people with Normal Dinner and Delayed Dinner, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung-Chih Chen (+886277496979, yc.chen@ntnu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic health (Oral glucose tolerance test, OGTT) (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.