Body CompositionNCT03828812
Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
A study testing Breakfast promotion and Nighttime snack reduction in people with Body Composition and Blood Pressure, run by National Yang Ming Chiao Tung University.
Trial summary
The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Blood Pressure, Mealtimes
- What is being tested?
- Breakfast promotion and Nighttime snack reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Dec 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult
- Willing to participate
Who cannot join
- Being pregnant
- hemodialysis patients
- clinical diagnosis of cardiovascular diseases
- clinical diagnosis of cancer
- clinical diagnosis of dementia
- clinical diagnosis of eating disorders
- having metal orthopedic implants
- having pacemaker implanted
About this study
The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year changes in blood pressure and body composition.
- Conditions
- Body Composition, Blood Pressure, Mealtimes
- Being tested
- Breakfast promotion, Nighttime snack reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast promotionBehavioural
Recommendation of having breakfast daily
Nighttime snack reductionBehavioural
Recommendation of reducing frequency of nighttime snacking
| Study group | Role | What they receive |
|---|---|---|
| Breakfast promotion | Active comparator | Receiving the recommendation of daily breakfast Receives: Behavioral: Breakfast promotion |
| Nighttime snack reduction | Active comparator | Receiving the recommendation of reducing nighttime snack frequency Receives: Behavioral: Nighttime snack reduction |
| Breakfast promotion + nighttime snack reduction | Experimental | Receiving the recommendation of daily breakfast + reducing nighttime snack frequency Receives: Behavioral: Breakfast promotion; Behavioral: Nighttime snack reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kilogram
Measured: 1 year
Standing height
Height in meters
Measured: 1 year
Body fat%
Bioimpedance method (TANITA BC-418)
Measured: 1 year
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Systolic blood pressure
Measured in mmHg (Microlife BP 3MS1-4K)
Measured: 1 year
Diastolic blood pressure
Measured in mmHg (Microlife BP 3MS1-4K)
Measured: 1 year
Secondary outcomes (2)
Frequency of breakfast per week
Self-report food frequency questionnaire(0-7 days/week)
Measured: 1 year
Frequency of nighttime snacking per week
Self-report food frequency questionnaire(0-7 days/week)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Aug 2015
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Jen Chen, National Yang Ming Chiao Tung University
- Investigators
- Hsin-Jen Chen, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828812
- Sponsor's protocol ID
- YM104136E
- Status last verified
- Jun 2020
- First submitted
- 30 Jan 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen HJ, Tsai YC, Hsu YT, Chu J. Effect of recommendations of breakfast and late-evening snack habits on body composition and blood pressure: A pilot randomized trial. Chronobiol Int. 2024 Jul;41(7):1021-1033. doi: 10.1080/07420528.2024.2363492. Epub 2024 Jun 11.
PubMed 38860554
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
- ClinicalTrials.gov ID
- NCT03828812
- Acronym / sponsor ID
- YM104136E
- Conditions
- Body Composition, Blood Pressure, Mealtimes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Feb 2019 (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.
The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year changes in blood pressure and body composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast promotion | Active comparator | Behavioral: Breakfast promotionReceiving the recommendation of daily breakfast |
| Nighttime snack reduction | Active comparator | Behavioral: Nighttime snack reductionReceiving the recommendation of reducing nighttime snack frequency |
| Breakfast promotion + nighttime snack reduction | Experimental | Behavioral: Breakfast promotion, Behavioral: Nighttime snack reductionReceiving the recommendation of daily breakfast + reducing nighttime snack frequency |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult
- Willing to participate
Key exclusion criteria (8 listed)
- Being pregnant
- hemodialysis patients
- clinical diagnosis of cardiovascular diseases
- clinical diagnosis of cancer
- clinical diagnosis of dementia
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 |
|---|---|---|
| Breakfast promotionRecommendation of having breakfast daily | Behavioural | Breakfast promotion, Breakfast promotion + nighttime snack reduction |
| Nighttime snack reductionRecommendation of reducing frequency of nighttime snacking | Behavioural | Breakfast promotion + nighttime snack reduction, Nighttime snack reduction |
Primary outcome
Body weight
Time frame: 1 year
Body weight in kilogram
Standing height
Time frame: 1 year
Height in meters
Body fat%
Time frame: 1 year
Bioimpedance method (TANITA BC-418)
Body mass index
Time frame: 1 year
Weight and height will be combined to report BMI in kg/m^2
Systolic blood pressure
Time frame: 1 year
Measured in mmHg (Microlife BP 3MS1-4K)
Diastolic blood pressure
Time frame: 1 year
Measured in mmHg (Microlife BP 3MS1-4K)
2 secondary outcomes
Frequency of breakfast per week
Time frame: 1 year
Frequency of nighttime snacking per week
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 38860554Chen HJ, Tsai YC, Hsu YT, Chu J. Effect of recommendations of breakfast and late-evening snack habits on body composition and blood pressure: A pilot randomized trial. Chronobiol Int. 2024 Jul;41(7):1021-1033. doi: 10.1080/07420528.2024.2363492. Epub 2024 Jun 11.
- Individual participant dataSharing planned: Undecided
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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.
Hsin-Jen Chen, PhD principal investigator
National Yang Ming Chiao Tung University
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast promotion and Nighttime snack reduction in people with Body Composition and Blood Pressure, run by National Yang Ming Chiao Tung University.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828812, which also lists 1 linked publication.
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 25 Jun 2020.