Dietary Approaches for Cardiometabolic Health

Not Applicable

Completed

• Conditions: Blood Pressure; Obesity, Abdominal; Weight Loss; Dyslipidemias; Insulin Resistance
• Interventions: Behavioral: Standard Cardiometabolic Health Diet; Behavioral: Time Restricted Eating

• Registration Number: NCT03527290
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-17
• Primary Completion: 2018-07-31
• Study Completion: 2020-11-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Cardiometabolic Health Diet	Standard Cardiometabolic Health Diet	Participants will be instructed and counseled with standard clinical dietary guidance for improving cardiometabolic health, where the focus is on the content, specifically a dietary pattern that emphasizes vegetables, fruits, whole grains, legumes, nuts/seeds, low fat dairy, seafood, lean poultry and meat and avoidance of foods with high levels of sodium, added sugars, saturated fats, and trans fats. There is no prescription to reduce energy intake.
Time Restricted Eating	Time Restricted Eating	Participants will be instructed and counseled to incorporate a 12-hour Time Restricted Eating (TRE) regimen that begins upon waking and concludes within a 12-hour period (e.g. if wake at 6:30 AM then all caloric intake occurs between 6:30 AM and 6:30 PM). Water and non-caloric beverages (e.g. herbal tea) outside the period are encouraged as desired. There are no specific content or energy intake changes to the diet counseled or recommended as the focus of the counseling in this arm is timing of eating with innate circadian patterns and developing plans and approaches to follow this plan.

Primary Outcome Measures

Name	Time	Method
Triglyceride : HDL cholesterol ratio	8 weeks	Ratio of fasting triglycerides to HDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Weight	8 weeks	Body weight measured on calibrated scale
HOMA-IR	8 weeks	Estimation of HOMA-IR from fasting glucose and insulin
Objective sleep and physical activity habits	Run-in (up to 2 weeks), Intervention (8 weeks)	Measured with fitbit
Glucose	8 weeks	Fasting glucose
Insulin	8 weeks	Fasting insulin
Waist Circumference	8 weeks	Measured by standard approach utilized in NHANES
LDL cholesterol	8 weeks	LDL cholesterol
Blood pressure	8 weeks	Resting systolic and diastolic blood pressure
Diet Quality	Run-in (up to 2 weeks), Intervention (8 weeks)	Assessed by 2 unannounced recalls during run-in period and 3 during intervention
Post-hoc estimated energy intake	8 weeks	Estimated by utilizing NIDDK Body weight planner with weights measured over 8 weeks

Trial Locations

Locations (1)

Institute for Clinical and Translational Science; 🇺🇸 Irvine, California, United States