Insulin Resistance Clinical Trial
— DACHOfficial title:
Dietary Approaches for Improving Cardiometabolic Health
Verified date | March 2021 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Clinical and Translational Science | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
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 |
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