Dietary Approaches for Cardiometabolic Health

Insulin Resistance Clinical Trial

— DACH  

Official title:

Dietary Approaches for Improving Cardiometabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527290
• Other study ID #: 2017-3929
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: November 5, 2020

Study information

• Verified date: March 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 5, 2020
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Institute for Clinical and Translational Science	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

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