An interventional study of Time Restricted Eating and Standard Cardiometabolic Health Diet in Obesity, Abdominal, Dyslipidemias and Insulin Resistance, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Prevention
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.
283 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 223 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →University of California, Irvine is the lead sponsor of 474 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
Triglyceride : HDL cholesterol ratio
Ratio of fasting triglycerides to HDL cholesterol
Time frame: 8 weeks
HOMA-IR
Estimation of HOMA-IR from fasting glucose and insulin
Time frame: 8 weeks
Glucose
Fasting glucose
Time frame: 8 weeks
Insulin
Fasting insulin
Time frame: 8 weeks
LDL cholesterol
LDL cholesterol
Time frame: 8 weeks
Weight
Body weight measured on calibrated scale
Time frame: 8 weeks
Waist Circumference
Measured by standard approach utilized in NHANES
Time frame: 8 weeks
Diet Quality
Assessed by 2 unannounced recalls during run-in period and 3 during intervention
Time frame: 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
Time frame: 8 weeks
Objective sleep and physical activity habits
Measured with fitbit
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Blood pressure
Resting systolic and diastolic blood pressure
Time frame: 8 weeks
Eating duration
Glycemic data from blinded continuous glucose monitor to estimate actual daily eating period
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Plan to share: Undecided — We plan to make this available to other researchers upon completion of the pilot study, publication, and receiving IRB approval to do so.
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jul 2018, 6 months.
Of 106 non-industry interventional studies with no phase under Obesity, Abdominal, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 6 months is below that.
Counting every sponsor, half of 115 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of California, Irvine →