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Preliminary Effect of Food Processing and Sweeteners on Glycemic and Metabolic Measures
N/A
Waitlist Available
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each 14-day period
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing foods sweetened with allulose, a zero-calorie sugar, on people with prediabetes, diabetes, or high metabolic risk. The goal is to see if replacing regular sugar with allulose can reduce overall sugar intake and improve blood sugar levels. D-allulose is a non-calorie rare monosaccharide with 70% sweetness of sucrose, which has shown anti-diabetes effects in Asian populations.
Eligible Conditions
- High Blood Sugar
- High Blood Pressure
- Eating Habits
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each 14-day period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each 14-day period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Glycemic Variability (and specifically the Coefficient of Variation -CV)
Secondary study objectives
Blood pressure
CGM Mean glucose
CGM Time in Range
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Whole and minimally processed and sweetened foods (low processed and low added sugar)Experimental Treatment1 Intervention
This period emphasizes incorporating minimally processed (e.g., intact whole grains) foods with minimal to no added sugar, aligning added sugar intake levels with recommendations from the American Heart Association and Dietary guidelines.
Consume at least 1 daily serving of the chosen, minimal to no sweetened breakfast food in place of "usual" sweetened breakfast cereal/cereal-granola bar and consume a whole piece of fruit (or serving of fruit) in place of a sweetened baked goods/candy/desserts (at least 1 daily serving).
* If they eat peanuts or nuts, consume plain or dry-roasted (no to low sodium) nuts/peanuts at least 3 days a week (1 serving), or as frequently as usual habits if more often
* If consume sweetened beverages (artificial or regular) or sweetened coffee or tea, consume unsweetened coffee or tea and consume plain water in place of the sweetened beverages at the same frequency/amount that usually do
Group II: Regular sweetened commercial foods (processed and high added sugar)Experimental Treatment1 Intervention
This is the "usual" habits period. Participants consume the chosen, sweetened commercial products of their choice in the breakfast cereal/cereal-granola bar category (at least 1 daily serving) and sweetened baked goods/candy/desserts (at least 1 daily serving).
* If they eat peanuts or nuts, and willingly consume chocolate covered peanuts or nuts, they will eat regular sweetened chocolate covered nuts/peanuts at least 3 days a week (1 serving/day), or as frequently as their usual habits if more often.
* If they consume sweetened beverages (artificial or regular) or sweetened coffee or tea, they will consume these regular sweetened beverages as they usually do.
Group III: Allulose sweetened commercial foods (processed and low added sugar)Experimental Treatment1 Intervention
This period emphasizes minimizing added sugar, aligning intake levels with recommendations from the AHA and Dietary guidelines by consuming allulose sweetened products.
Participants will eat at least 1 daily serving of the chosen, provided allulose sweetened breakfast/cereal-granola bar, and at least 1 daily serving of allulose sweetened baked goods/candy/desserts in place of the usual sweetened products from these food categories.
* If they eat peanuts or nuts, and willingly consume chocolate covered peanuts or nuts, eat allulose sweetened chocolate covered nuts/peanuts at least 3 days a week (1 serving/day), or as frequently as usual habits if more often.
* If they consume sweetened beverages (artificial or regular) or sweetened coffee or tea, consume allulose sweetened beverages in place of their artificial or regular sweetened beverages (provided commercial and/or syrups), and sweeten coffee or tea with the provided allulose sweetener. Do this according to usual habits.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,933,063 Total Patients Enrolled