Obesity, AbdominalDACHNCT03527290
Dietary Approaches for Cardiometabolic Health
A study testing Time Restricted Eating and Standard Cardiometabolic Health Diet in people with Obesity, Abdominal and Dyslipidemias, run by University of California, Irvine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Dyslipidemias, Insulin Resistance
- What is being tested?
- Time Restricted Eating and Standard Cardiometabolic Health Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 5 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- active usual smoking (tobacco or marijuana)
- alcohol intake > 3 drinks/day
- pregnancy, current lactation, or plans to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Clinical and Translational Science
Irvine, California, 92697
About this study
Official title: Dietary Approaches for Improving Cardiometabolic Health
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.
- Being tested
- Time Restricted Eating, Standard Cardiometabolic Health Diet
- Medical subject headings
- Obesity, Abdominal, Dyslipidemias, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
Also called 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 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 DietBehavioural
Also called STD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Cardiometabolic Health Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride : HDL cholesterol ratio
Ratio of fasting triglycerides to HDL cholesterol
Measured: 8 weeks
Secondary outcomes (10)
HOMA-IR
Estimation of HOMA-IR from fasting glucose and insulin
Measured: 8 weeks
Glucose
Fasting glucose
Measured: 8 weeks
Insulin
Fasting insulin
Measured: 8 weeks
LDL cholesterol
LDL cholesterol
Measured: 8 weeks
Weight
Body weight measured on calibrated scale
Measured: 8 weeks
Waist Circumference
Measured by standard approach utilized in NHANES
Measured: 8 weeks
Diet Quality
Assessed by 2 unannounced recalls during run-in period and 3 during intervention
Measured: 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
Measured: 8 weeks
Objective sleep and physical activity habits
Measured with fitbit
Measured: Run-in (up to 2 weeks), Intervention (8 weeks)
Blood pressure
Resting systolic and diastolic blood pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start15 Jan 2018
- Primary completion31 Jul 2018
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Odegaard, University of California, Irvine
- Investigators
- Andrew Odegaard, PhD, MPH, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527290
- Sponsor's protocol ID
- 2017-3929
- Acronym
- DACH
- Status last verified
- Mar 2021
- First submitted
- 26 Apr 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to make this available to other researchers upon completion of the pilot study, publication, and receiving IRB approval to do so.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches for Improving Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03527290
- Acronym / sponsor ID
- DACH / 2017-3929
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time Restricted EatingParticipants 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. |
| Standard Cardiometabolic Health Diet | Active comparator | Behavioral: Standard Cardiometabolic Health DietParticipants 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. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingAlso: TREThe 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. | Behavioural | Time Restricted Eating |
| Standard Cardiometabolic Health DietAlso: STDThe 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. | Behavioural | Standard Cardiometabolic Health Diet |
Primary outcome
Triglyceride : HDL cholesterol ratio
Time frame: 8 weeks
Ratio of fasting triglycerides to HDL cholesterol
10 secondary outcomes
HOMA-IR
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
LDL cholesterol
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Diet Quality
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Post-hoc estimated energy intake
Time frame: 8 weeks
Objective sleep and physical activity habits
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Blood pressure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided. We plan to make this available to other researchers upon completion of the pilot study, publication, and receiving IRB approval to do so.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Odegaard, PhD, MPH principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating and Standard Cardiometabolic Health Diet in people with Obesity, Abdominal and Dyslipidemias, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride : HDL cholesterol ratio (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.