Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT05658757
Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes with HbA1c \< 8.5%, or prediabetes (defined by HbA1c of 5.7-6.4%) or fasting glucose (≥ 100 mg/dl )
* or abdominal obesity (defined by sex and ethnic based thresholds: Europid/Sub-Saharan Africa/E Med-Middle E ethnicity (M 94 cm / F 90 cm), S/SE/E Asian and ethnic S and Central Americans (M 90 cm / F 80 cm) with at least one other abnormality from the following: (elevated triglycerides (≥ 150 mg/dl), elevated LDL (≥ 130 mg/dl or Rx), low HDL (\<40 mg/dl M, \<50 mg/dl F, or Rx), elevated blood pressure (\>130 systolic or \> 85 diastolic, or Rx).
* Free of clinically significant or unstable pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality; or currently pregnant.
* Weight stable for past 3 months (+- 5% of current body weight) and not planning to lose or gain weight over study period.
* able to provide informed consent
* otherwise healthy (beyond above noted health criteria), who meet the following criteria: interested in participating in and adhering to the prescribed 6-week long study comprised of 3, 2-week periods
* access to a telephone
* a stable dietary history, defined as neither introducing nor eliminating a major food group in their diet for at least the previous month
* eat a breakfast meal or morning snack (defined as an eating occasion after waking and before eating a lunch meal) 5 or more times a week on average
* 2 servings a day of food/beverage with \> 20% of added sugar intake for day (10 g/serving) as estimated from dietary and beverage survey
Exclusion Criteria:
* Never diagnosed with Alzheimer's disease or related dementias, or any cognitive related conditions (interfere with ability to participate and respond to outcome assessments)
* Currently pregnant (self-report) or planning to become pregnant during study period, -Current participation in another interventional clinical trial
* Previous randomization in the study
* Current treatment for cancer
* Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg
* Major surgery planned during study duration
* Any disease or health condition which requires adherence to a specific diet/eating pattern that would prohibit participation
* Food insecurity assessed by Six-Item Short Form of the Food Security Survey Module (score \> 1)
* Not responsible for choice of \> 50% of dietary intake,
* work or obligations that require being awake during 3rd or overnight shift
* \> 14 alcohol drinks /week
* heavy marijuana/THC product usage (\> 5 days / week)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
99 Years
Study:
NCT05658757
Study Brief:
Protocol Section:
NCT05658757