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Dietary Approaches for Cardiometabolic Health (DACH)

Primary Purpose

Obesity, Abdominal, Dyslipidemias, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Eating
Standard Cardiometabolic Health Diet
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Abdominal

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Institute for Clinical and Translational Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time Restricted Eating

Standard Cardiometabolic Health Diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

Triglyceride : HDL cholesterol ratio
Ratio of fasting triglycerides to HDL cholesterol

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2018
Last Updated
March 26, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT03527290
Brief Title
Dietary Approaches for Cardiometabolic Health
Acronym
DACH
Official Title
Dietary Approaches for Improving Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Dyslipidemias, Insulin Resistance, Blood Pressure, Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants are blinded to the nature of the other intervention so as not to contaminate the intervention. The clinical research staff taking the measurements is also blinded to the respective intervention the participant has been randomized to.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Eating
Arm Type
Experimental
Arm 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.
Arm Title
Standard Cardiometabolic Health Diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Eating
Other Intervention Name(s)
TRE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Cardiometabolic Health Diet
Other Intervention Name(s)
STD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triglyceride : HDL cholesterol ratio
Description
Ratio of fasting triglycerides to HDL cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
HOMA-IR
Description
Estimation of HOMA-IR from fasting glucose and insulin
Time Frame
8 weeks
Title
Glucose
Description
Fasting glucose
Time Frame
8 weeks
Title
Insulin
Description
Fasting insulin
Time Frame
8 weeks
Title
LDL cholesterol
Description
LDL cholesterol
Time Frame
8 weeks
Title
Weight
Description
Body weight measured on calibrated scale
Time Frame
8 weeks
Title
Waist Circumference
Description
Measured by standard approach utilized in NHANES
Time Frame
8 weeks
Title
Diet Quality
Description
Assessed by 2 unannounced recalls during run-in period and 3 during intervention
Time Frame
Run-in (up to 2 weeks), Intervention (8 weeks)
Title
Post-hoc estimated energy intake
Description
Estimated by utilizing NIDDK Body weight planner with weights measured over 8 weeks
Time Frame
8 weeks
Title
Objective sleep and physical activity habits
Description
Measured with fitbit
Time Frame
Run-in (up to 2 weeks), Intervention (8 weeks)
Title
Blood pressure
Description
Resting systolic and diastolic blood pressure
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Eating duration
Description
Glycemic data from blinded continuous glucose monitor to estimate actual daily eating period
Time Frame
Run-in (up to 2 weeks), Intervention (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Odegaard, PhD, MPH
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Translational Science
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Dietary Approaches for Cardiometabolic Health

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