Dietary Approaches for Cardiometabolic Health

NCT03527290 | Completed

• 1 other identifier: 2017-3929
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Triglyceride : HDL cholesterol ratio

  Ratio of fasting triglycerides to HDL cholesterol

  8 weeks

Secondary Outcomes (10)

• HOMA-IR

  8 weeks

• Glucose

  8 weeks

• Insulin

  8 weeks

• LDL cholesterol

  8 weeks

• Weight

  8 weeks

Other Outcomes (1)

• Eating duration

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

Study Arms (2)

Time Restricted Eating

EXPERIMENTAL

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

Standard Cardiometabolic Health Diet

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: TRE

Time Restricted Eating

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.

Also known as: STD

Standard Cardiometabolic Health Diet

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Institute for Clinical and Translational Science

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal; Dyslipidemias; Insulin Resistance; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Body Weight Changes

Study Officials

• Andrew Odegaard, PhD, MPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 17, 2018
• Study Start: January 15, 2018
• Primary Completion: July 31, 2018
• Study Completion: November 5, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

US (1)