Preliminary Effect of Food Processing and Sweeteners on Glycemic and Metabolic Measures

NCT05658757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-03

No results posted yet for this study

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.

Conditions

  • Blood Sugar; High
  • Blood Pressure
  • Dietary Habits

Interventions

OTHER

Regular sweetened commercial foods

This is your "usual" habits period. Consume the chosen, sweetened commercial products of your 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 you eat peanuts or nuts, and willingly consume chocolate covered peanuts or nuts, eat the regular sweetened chocolate covered nuts/peanuts at least 3 days a week (1 serving/day), or as frequently as your usual habits if more often. * If you consume sweetened beverages (artificial or regular) or sweetened coffee or tea, consume these regular sweetened beverages as you usually do.

OTHER

Allulose sweetened commercial foods

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.

OTHER

Whole and minimally processed and sweetened foods

Consume at least 1 daily serving of the chosen, minimal to no sweetened breakfast product in place of your "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 you 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 your usual habits if more often * If you 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 you usually do. 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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05658757 on ClinicalTrials.gov