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OpenTrials
Completed

NCT Number: NCT03527290

Dietary Approaches for 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.

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Key information

Conditions

Obesity, Abdominal Blood Pressure Body Weight Body Weight Changes Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical and Translational Science

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time restricted eating

Behavioral

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

Standard Cardiometabolic Health Diet

Behavioral

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

Primary outcomes

  1. Triglyceride : HDL cholesterol ratio

    Time frame: 8 weeks

    Ratio of fasting triglycerides to HDL cholesterol

Secondary outcomes

  1. HOMA-IR

    Time frame: 8 weeks

    Estimation of HOMA-IR from fasting glucose and insulin

  2. Glucose

    Time frame: 8 weeks

    Fasting glucose

  3. Insulin

    Time frame: 8 weeks

    Fasting insulin

  4. LDL cholesterol

    Time frame: 8 weeks

    LDL cholesterol

  5. Weight

    Time frame: 8 weeks

    Body weight measured on calibrated scale

  6. Waist Circumference

    Time frame: 8 weeks

    Measured by standard approach utilized in NHANES

  7. Diet Quality

    Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)

    Assessed by 2 unannounced recalls during run-in period and 3 during intervention

  8. Post-hoc estimated energy intake

    Time frame: 8 weeks

    Estimated by utilizing NIDDK Body weight planner with weights measured over 8 weeks

  9. Objective sleep and physical activity habits

    Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)

    Measured with fitbit

  10. Blood pressure

    Time frame: 8 weeks

    Resting systolic and diastolic blood pressure

Other outcomes

  1. Eating duration

    Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)

    Glycemic data from blinded continuous glucose monitor to estimate actual daily eating period

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Dietary Approaches for Improving Cardiometabolic Health

Acronym: DACH

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
May 17, 2018
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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