Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure

NCT ID: NCT03828812

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Body Composition Blood Pressure Mealtimes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Breakfast promotion

Receiving the recommendation of daily breakfast

Group Type ACTIVE_COMPARATOR

Breakfast promotion

Intervention Type BEHAVIORAL

Recommendation of having breakfast daily

Nighttime snack reduction

Receiving the recommendation of reducing nighttime snack frequency

Group Type ACTIVE_COMPARATOR

Nighttime snack reduction

Intervention Type BEHAVIORAL

Recommendation of reducing frequency of nighttime snacking

Breakfast promotion + nighttime snack reduction

Receiving the recommendation of daily breakfast + reducing nighttime snack frequency

Group Type EXPERIMENTAL

Breakfast promotion

Intervention Type BEHAVIORAL

Recommendation of having breakfast daily

Nighttime snack reduction

Intervention Type BEHAVIORAL

Recommendation of reducing frequency of nighttime snacking

Interventions

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Breakfast promotion

Recommendation of having breakfast daily

Intervention Type BEHAVIORAL

Nighttime snack reduction

Recommendation of reducing frequency of nighttime snacking

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult
* Willing to participate

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Hsin-Jen Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsin-Jen Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

References

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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.

Reference Type DERIVED
PMID: 38860554 (View on PubMed)

Other Identifiers

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YM104136E

Identifier Type: -

Identifier Source: org_study_id

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