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

NCT05658757 | Completed

• 1 other identifier: 1477
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days (each period)

Secondary Outcomes (9)

• CGM Time in Range

  14 days (each period)

• CGM Mean glucose

  14 days (each period)

• Blood pressure

  End of each 14-day period

• Dietary Quality

  Each 14-day period

• Weight (kg)

  End of each 14-day period

Study Arms (3)

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.

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.

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

Other: Whole and minimally processed and sweetened foods

Interventions

Regular sweetened commercial foods OTHER

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.

Also known as: Processed and high added sugar

Regular sweetened commercial foods (processed and high added sugar)

Allulose sweetened commercial foods OTHER

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.

Also known as: Processed and low added sugar

Allulose sweetened commercial foods (processed and low added sugar)

Whole and minimally processed and sweetened foods OTHER

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.

Also known as: Low processed and low added sugar

Whole and minimally processed and sweetened foods (low processed and low added sugar)

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• servings a day of food/beverage with \> 20% of added sugar intake for day (10 g/serving) as estimated from dietary and beverage survey

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Feeding Behavior

Interventions

Microscopy, Electron, Scanning Transmission

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are aware of study arm, but measured primary preliminary outcome is from a blinded CGM. Additionally, participants are not provided any of measured data during participation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 21, 2022
• Study Start: November 9, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

US (1)