Blood Pressure, Dyslipidemias, Insulin Resistance, Obesity, Abdominal, Weight Loss
Conditions
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.
Interventions
BEHAVIORALTime 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.
BEHAVIORALStandard 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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride : HDL cholesterol ratio | 8 weeks | Ratio of fasting triglycerides to HDL cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | 8 weeks | Estimation of HOMA-IR from fasting glucose and insulin |
| Glucose | 8 weeks | Fasting glucose |
| Insulin | 8 weeks | Fasting insulin |
| LDL cholesterol | 8 weeks | LDL cholesterol |
| Weight | 8 weeks | Body weight measured on calibrated scale |
| Diet Quality | Run-in (up to 2 weeks), Intervention (8 weeks) | Assessed by 2 unannounced recalls during run-in period and 3 during intervention |
| Post-hoc estimated energy intake | 8 weeks | Estimated by utilizing NIDDK Body weight planner with weights measured over 8 weeks |
| Objective sleep and physical activity habits | Run-in (up to 2 weeks), Intervention (8 weeks) | Measured with fitbit |
| Blood pressure | 8 weeks | Resting systolic and diastolic blood pressure |
| Waist Circumference | 8 weeks | Measured by standard approach utilized in NHANES |
Other
| Measure | Time frame | Description |
|---|---|---|
| Eating duration | Run-in (up to 2 weeks), Intervention (8 weeks) | Glycemic data from blinded continuous glucose monitor to estimate actual daily eating period |
Countries
United States
Outcome results
None listed