Dietary Approaches for Cardiometabolic Health

Study Overview
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Brief Summary
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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.

Official Title
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Dietary Approaches for Improving Cardiometabolic Health

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

Intervention / Treatment
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* Behavioral: Time Restricted Eating
* Behavioral: Standard Cardiometabolic Health Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time Restricted Eating<br>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<br>* 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.<br>* Other names: TRE;|
| Active Comparator: Standard Cardiometabolic Health Diet<br>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<br>* 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.<br>* Other names: STD;|

What is the study measuring?
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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 |