Dietary Approaches for Cardiometabolic Health (DACH)

Dietary Approaches for Improving Cardiometabolic Health

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Dyslipidemias; Weight Loss; Blood Pressure; Obesity, Abdominal
• Intervention / Treatment: Behavioral: Time Restricted Eating; Behavioral: Standard Cardiometabolic Health Diet

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Institute for Clinical and Translational Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Time Restricted Eating; The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts related to circadian rhythms, metabolism and TRE; and the evidence demonstrating benefit of TRE in animal models and humans. The goal is provide rationale for the potential benefits of a TRE approach. In addition, the RD sessions focus on developing a plan for successfully implementing a TRE approach, identifying challenges for adherence, and a plan for dealing with real or potential challenges. The counseling is focused the TRE concept, with no specific direction or counseling related to modifying the content of the participant's diet or any prescription to reduce energy intake.; Other Names: TRE
Active Comparator: 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.	Behavioral: Standard Cardiometabolic Health Diet; The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts and known benefits related to eating a diet for cardiometabolic health and weight management recommended by the American Heart Association and the Academy of Nutrition and Dietetics as a standard of practice for dietitians in healthcare settings. The RD sessions focus on adopting a dietary pattern aligned with this approach, identifying challenges to adopting this dietary pattern, and education and plans for dealing with real or potential challenges. The counseling gives no direction related to modifying the timing of dietary intake or any prescription to reduce energy intake.; Other Names: STD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride : HDL cholesterol ratio	Ratio of fasting triglycerides to HDL cholesterol	8 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating duration	Glycemic data from blinded continuous glucose monitor to estimate actual daily eating period	Run-in (up to 2 weeks), Intervention (8 weeks)

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Andrew Odegaard, PhD, MPH, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Hyperinsulinism; Body Weight Changes; Lipid Metabolism Disorders; Obesity; Weight Loss; Dyslipidemias; Insulin Resistance; Obesity, Abdominal
• Other Study ID Numbers: 2017-3929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We plan to make this available to other researchers upon completion of the pilot study, publication, and receiving IRB approval to do so.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No