Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05658757 |
Other study ID # |
1477 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 9, 2022 |
Est. completion date |
April 19, 2023 |
Study information
Verified date |
April 2023 |
Source |
University of California, Irvine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.