Clinical trial NCT03527290: Dietary Approaches for Cardiometabolic Health
Official title: Dietary Approaches for Improving Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Dyslipidemias
Insulin Resistance
Blood Pressure
Weight Loss
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study aims to recruit 30 adults with abdominal obesity, without major chronic disease, and test whether clinical dietary advice that is solely focused on the timing of eating (time restricted eating), has an effect on cardiometabolic health compared to standard dietary advice for cardiometabolic health, which is focused on content. The goal of this pilot study is to develop and hone dietary counseling approaches for time restricted eating for RD's in a clinical practice paradigm, and collect data on testing this intervention compared to standard dietary counseling approaches for cardiometabolic health.


Eligibility criteria: Inclusion Criteria:

* Abdominal obesity (waist circumference ≥35" for women and ≥40" for men; if Asian ethnicity, ≥35" for men and ≥31.5" for women)
* weight stable over the previous 2 months
* medications stable for \> 3 months
* self-reported 24-hr sleep-wake patterns within the appropriate range as defined by the National Sleep Foundation (self-reported habitual sleep duration 6-10 hours during nocturnal hours)
* regular meal patterns
* from the greater UCI and Orange county area
* willing to incorporate a dietary approach aimed at improving cardiometabolic health and weight management
* able to speak, read and understand English or Spanish

Exclusion Criteria:

* Self-reported unstable hypertension
* Type 1 or 2 diabetes mellitus
* heart, renal, or liver disease
* cancer or active neoplasms
* hyperthyroidism unless treated and under control
* taking any medications known to affect clinical risk measures of interest or weight/energy expenditure (except for stable blood pressure medication)
* active usual smoking (tobacco or marijuana)
* alcohol intake \> 3 drinks/day
* pregnancy, current lactation, or plans to become pregnant during the study

Primary outcomes:
measure: Triglyceride : HDL cholesterol ratio
timeFrame: 8 weeks
Secondary outcomes:
measure: HOMA-IR
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
measure: Insulin
timeFrame: 8 weeks
measure: LDL cholesterol
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
measure: Waist Circumference
timeFrame: 8 weeks
measure: Diet Quality
timeFrame: Run-in (up to 2 weeks), Intervention (8 weeks)
measure: Post-hoc estimated energy intake
timeFrame: 8 weeks
measure: Objective sleep and physical activity habits
timeFrame: Run-in (up to 2 weeks), Intervention (8 weeks)
measure: Blood pressure
timeFrame: 8 weeks
Other outcomes:
measure: Eating duration
timeFrame: Run-in (up to 2 weeks), Intervention (8 weeks)
Locations:
city: Irvine
country: United States
facility: Institute for Clinical and Translational Science
state: California
Study officials:
affiliation: University of California, Irvine
name: Andrew Odegaard, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: