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NCT05658757
Preliminary Effect of Food Processing and Sweeteners on Glycemic and Metabolic Measures
Conditions: Blood Sugar; High, Blood Pressure, Dietary Habits
Sex: All
Ages: 20 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 15
Sponsor: University of California, Irvine
Location: United States
Summary
The average adult in the US consumes over 1/3 of a cup of sugar each day, or nearly 300 calories worth, with the primary sources being from beverages, desserts and sweet snacks, candy, additions to beverages, and foods such as breakfast cereals.
This is a risky health behavior, as high added sugar intake relates to higher risk of gaining weight, blood sugar disorders such as type 2 diabetes, plus heart disease and various cancers.
Thus, high added sugar intake is problematic, and something in need of reducing.
Therefore, the investigators are proposing to test how commercial foods sweetened with a new, FDA approved rare sugar with net zero calories (allulose), that is derived from dried fruits, brown sugar, and maple syrup may impact added sugar intake and usual blood sugar levels.
The investigators are doing this by a randomized trial, in which the investigators will recruit participants with abnormal blood sugars (prediabetes or diabetes) or higher metabolic risk (bigger waist and elevated blood pressure or blood cholesterol) and ask them in random order to include foods in their usual dietary intake that are sweetened by regular sugars (regular sugar), foods that are sweetened by the zero calorie rare sugar allulose (low added sugar), or low added sugar intake by higher intake of fresh fruits and minimally processed and sweetened foods in place of usual sweetened foods.
The investigators will measure their usual blood sugar levels for each of these 3 different 2- week periods with a blood glucose monitor, along with what they eat each of those periods, their blood pressure, and how the different dietary approaches impact how they feel.
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 consentotherwise 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 periodsaccess to a telephonea stable dietary history, defined as neither introducing nor eliminating a major food group in their diet for at least the previous montheat 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 average2 servings a day of food/beverage with > 20% of added sugar intake for day (10 g/serving) as estimated from dietary and beverage surveyExclusion 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 trialPrevious randomization in the studyCurrent treatment for cancerSystolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm HgMajor surgery planned during study durationAny disease or health condition which requires adherence to a specific diet/eating pattern that would prohibit participationFood 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 /weekheavy marijuana/THC product usage (> 5 days / week)
Source: ClinicalTrials.gov (NCT05658757). StuddyBuddy aggregates publicly available trial information.