Dietary Approaches for Cardiometabolic Health (DACH)

University of California Irvine (UCI)

Status: Completed

Conditions: Weight Loss; Obesity, Abdominal; Dyslipidemias; Insulin Resistance; Blood Pressure

Treatments: Behavioral: Time Restricted Eating; Behavioral: Standard Cardiometabolic Health Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03527290

2017-3929

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Time Restricted Eating

Experimental group

Description:

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.

Treatment:

Behavioral: Time Restricted Eating

Standard Cardiometabolic Health Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Cardiometabolic Health Diet