Blood Sugar; HighNCT05658757
Preliminary Effect of Food Processing and Sweeteners on Glycemic and Metabolic Measures
A study testing Regular sweetened commercial foods, Allulose sweetened commercial foods and Whole and minimally processed and sweetened foods in people with Blood Sugar; High and Blood Pressure, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar; High, Blood Pressure, Dietary Habits
- What is being tested?
- Regular sweetened commercial foods, Allulose sweetened commercial foods and Whole and minimally processed and sweetened foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 consent
- otherwise 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 periods
Show all 10Show fewer
- access to a telephone
- a stable dietary history, defined as neither introducing nor eliminating a major food group in their diet for at least the previous month
- eat 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 average
- 2 servings a day of food/beverage with > 20% of added sugar intake for day (10 g/serving) as estimated from dietary and beverage survey
Who cannot join
- 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 trial
- Previous randomization in the study
- Current treatment for cancer
- Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg
- Major surgery planned during study duration
Show all 12Show fewer
- Any disease or health condition which requires adherence to a specific diet/eating pattern that would prohibit participation
- Food 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 /week
- heavy marijuana/THC product usage (> 5 days / week)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: A Randomized Crossover Pilot Study Investigating the Impact of a "Natural" Low-Calorie Sweetener (Allulose) on Glycemic and Metabolic Measures
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.
Read the 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
- Being tested
- Regular sweetened commercial foods, Allulose sweetened commercial foods, Whole and minimally processed and sweetened foods
- Medical subject headings
- Hyperglycemia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular sweetened commercial foodsOther
Also called Processed and high added sugar
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.
Allulose sweetened commercial foodsOther
Also called Processed and low added sugar
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.
Whole and minimally processed and sweetened foodsOther
Also called Low processed and low added sugar
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular sweetened commercial foods (processed and high added sugar) | Experimental | 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. Receives: Other: Regular sweetened commercial foods |
| Allulose sweetened commercial foods (processed and low added sugar) | Experimental | 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. Receives: Other: Allulose sweetened commercial foods |
| Whole and minimally processed and sweetened foods (low processed and low added sugar) | Experimental | 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 Receives: Other: Whole and minimally processed and sweetened foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability (and specifically the Coefficient of Variation -CV)
Measured via Blinded Continuous Glucose Monitoring (CGM). We will collect CGM data over the course of the study during each of the three, 14-day periods as the primary clinical measure. This is an apt measure that is meaningful and interpretable across the spectrum of glycemic/metabolic abnormality to frank type 2 diabetes. The inherent major influence of CV is postprandial glucose, which is meaningful across the same spectrum for disease risk. We will use the Abbott Freestyle Libre Pro system.
Measured: 14 days (each period)
Secondary outcomes (9)
CGM Time in Range
the amount of time spent in the target blood glucose (blood sugar) range-between 70 and 180 mg/dL
Measured: 14 days (each period)
CGM Mean glucose
Mean glucose (mg/dL)
Measured: 14 days (each period)
Blood pressure
Systolic and Diastolic blood pressure, standard clinical measurement
Measured: End of each 14-day period
Dietary Quality
HEI dietary quality score as derived from 3 unannounced 24-hour dietary recalls each period (1 weekend, 2 non-consecutive weekdays), scored 0-100, higher = better diet quality
Measured: Each 14-day period
Weight (kg)
Weight measured on standardized scale
Measured: End of each 14-day period
Physical activity
Mean MET/hour objective measured via Activpal
Measured: 7-days Each period
Sleep
Mean hours/day Objectively measured via Activpal
Measured: 7-days Each period
Food preference and food reward
Leeds Food Preference Questionnaire
Measured: End of each 14-day period
Quality of life and well-being (Short-Form 12, SF-12)
SF-12 The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. with a range from 0 to 100, with higher scores representing better self-reported health
Measured: End of each 14-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start9 Nov 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sugar; HighStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Odegaard, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658757
- Sponsor's protocol ID
- 1477
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Pilot Study Investigating the Impact of a "Natural" Low-Calorie Sweetener (Allulose) on Glycemic and Metabolic Measures
- ClinicalTrials.gov ID
- NCT05658757
- Acronym / sponsor ID
- 1477
- Conditions
- Blood Sugar; High, Blood Pressure, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular sweetened commercial foods (processed and high added sugar) | Experimental | Other: Regular sweetened commercial foodsThis 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. |
| Allulose sweetened commercial foods (processed and low added sugar) | Experimental | Other: Allulose sweetened commercial foodsThis 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. |
| Whole and minimally processed and sweetened foods (low processed and low added sugar) | Experimental | Other: Whole and minimally processed and sweetened foodsThis 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 |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 consent
Key exclusion criteria (12 listed)
- 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 trial
- Previous randomization in the study
- Current treatment for cancer
- Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular sweetened commercial foodsAlso: Processed and high added sugarThis 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 | Regular sweetened commercial foods (processed and high added sugar) |
| Allulose sweetened commercial foodsAlso: Processed and low added sugarThis 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 | Allulose sweetened commercial foods (processed and low added sugar) |
| Whole and minimally processed and sweetened foodsAlso: Low processed and low added sugarConsume 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. | Other | Whole and minimally processed and sweetened foods (low processed and low added sugar) |
Primary outcome
Glycemic Variability (and specifically the Coefficient of Variation -CV)
Time frame: 14 days (each period)
Measured via Blinded Continuous Glucose Monitoring (CGM). We will collect CGM data over the course of the study during each of the three, 14-day periods as the primary clinical measure. This is an apt measure that is meaningful and interpretable across the spectrum of glycemic/metabolic abnormality to frank type 2 diabetes. The inherent major influence of CV is postprandial glucose, which is meaningful across the same spectrum for disease risk. We will use the Abbott Freestyle Libre Pro system.
9 secondary outcomes
CGM Time in Range
Time frame: 14 days (each period)
CGM Mean glucose
Time frame: 14 days (each period)
Blood pressure
Time frame: End of each 14-day period
Dietary Quality
Time frame: Each 14-day period
Weight (kg)
Time frame: End of each 14-day period
Physical activity
Time frame: 7-days Each period
Sleep
Time frame: 7-days Each period
Food preference and food reward
Time frame: End of each 14-day period
Quality of life and well-being (Short-Form 12, SF-12)
Time frame: End of each 14-day period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular sweetened commercial foods, Allulose sweetened commercial foods and Whole and minimally processed and sweetened foods in people with Blood Sugar; High and Blood Pressure, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Variability (and specifically the Coefficient of Variation -CV) (time frame: 14 days (each period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.