NCT05658757

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

A Randomized Crossover Pilot Study Investigating the Impact of a "Natural" Low-Calorie Sweetener (Allulose) on Glycemic and Metabolic Measures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

The average adult in the United States consumes around 17 teaspoons a day of added sugar, or nearly 280 calories, far exceeding recommended levels; and the leading sources of added sugars in the US diet are sugar-sweetened beverages, desserts and sweet snacks, candy, additions to coffee and teas, and substantial but insidious levels in foods such as brefakfast cereals. Indeed, this is fueled by intake of ultra-processed foods, which provide 58 % of energy intake and 89 % of added sugars in the American diet. A significant body of evidence links high intake of added sugars to the spectrum of chronic diseases which predominate the current, era, particularly those impacted by glycemia, and particularly postprandial glycemia, which has a clear role in health and disease. Thus, it is no surprise that a leading health indicator for Healthy People 2030 is to "reduce consumption of added sugars by people aged 2 years and over". Despite myriad efforts to reduce sugar-sweetened beverage intake (which has occurred on some levels), levels of added sugars have continued to increase over the past decade. A major bottleneck in addressing the goal of reducing added sugars in the American diet has been the lack of products lower in added sugars or sugar-free that the average adult in the US finds palatable and doesn't carry ingrained stigma or taste preferences which limit intake (i.e., sweetened by FDA approved artificial sweeteners). Very recently, a potential solution to this bottleneck has appeared in the form of allulose, a natural "zero calorie" sweetener found in small amounts of maple syrup, dried fruits, and brown sugar. This sweetener is intended to be incorporated into bakery products, beverages, confectionaries, dairy products and as a straight sugar substitute. Additionally, there is preliminary evidence from basic science, and small trials in humans that shows benefit of intake in place of regular added sugar in both healthy populations and in individuals with type 2 diabetes in respect to glycemic dynamics. Thus, there is a need to begin testing whether intake of commercial products sweetened with allulose can indeed be an approach to reduce added sugar intake and improve glycemia, particularly in people with metabolic abnormalities who are more sensitive to added sugar intake. Therefore, the investigators are proposing the following specific aims for this pilot study. Aim 1: To inform hypotheses and test the preliminary effectiveness of the ability of commercial products sweetened with allulose to reduce added sugar intake and reduce measures of glycemia, the investigators will carry out a randomized crossover dietary intervention with provision of categories of participant chosen food with specific consumption instructions, that compares a period of intake of regular sweetened commercial foods (processed and high added sugar), a period of intake of allulose sweetened commercial products (processed and low added sugar), and a period emphasizing whole and minimally processed and sweetened foods (low processed and low added sugar). Aim 2: The investigators will measure dietary intake to estimate diet quality in each period, as well as measure blood pressure, weight, and psychosocial measures to provide a comprehensive initial impact of these approaches, and inform hypotheses for longer and more comprehensive future research.

Conditions

• Blood Sugar; High
• Blood Pressure
• Dietary Habits

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-09
• Primary completion: 2023-04-19
• Completion: 2023-04-19
• First posted: 2022-12-21
• Last updated: 2023-05-03

Locations

1 site across 1 country: United States