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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828812
• Other study ID #: YM104136E
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 decrease nighttime snacking on 1-year changes in blood pressure and body composition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Body Composition
• Mealtimes

Intervention

Behavioral:
• Breakfast promotion
Recommendation of having breakfast daily
• Nighttime snack reduction
Recommendation of reducing frequency of nighttime snacking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep quality score	Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality	1 year
Other	Mood status	Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods	1 year
Primary	Body weight	Body weight in kilogram	1 year
Primary	Standing height	Height in meters	1 year
Primary	Body fat%	Bioimpedance method (TANITA BC-418)	1 year
Primary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	1 year
Primary	Systolic blood pressure	Measured in mmHg (Microlife BP 3MS1-4K)	1 year
Primary	Diastolic blood pressure	Measured in mmHg (Microlife BP 3MS1-4K)	1 year
Secondary	Frequency of breakfast per week	Self-report food frequency questionnaire(0-7 days/week)	1 year
Secondary	Frequency of nighttime snacking per week	Self-report food frequency questionnaire(0-7 days/week)	1 year