Healthy DietNCT05408338
Acute Effects of Added Sugar Intake on Cerebrovascular Function and Brain Integrity
A study testing Low Added Sugar Meal and High Added Sugar Meal in people with Healthy Diet and Healthy Aging, run by University of Delaware at 1 site in United States.
Trial summary
This study will focus on acute effects of added sugars on brain health in a specific age group (30-64 years old). We will provide participants two meals (one meal containing 16 g of added sugars and the other containing 61 g of added sugars) and examine blood vessel function and brain structure using a MRI. Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Healthy Aging
- What is being tested?
- Low Added Sugar Meal and High Added Sugar Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 17 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 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide informed consent;
- Men and women within the ages of 30-64 years;
- Habitual added sugar intake of <150 kcal/day for men and <100kcal/day for women;
- No allergies/intolerance to ingredients in the study meal (e.g., nuts, gluten)
Who cannot join
- Blood chemistries indicative of abnormal liver enzymes and renal function;
- Abnormal blood chemistry marker that is +/-2.5x the upper or lower limit;
- Chronic clinical diseases (e.g., coronary artery, peripheral artery, or cerebrovascular diseases, diabetes (type 1 and type 2), stages 5-6 chronic kidney disease, chronic obstructive pulmonary disease);
- Major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
- Neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct);
- Current medication use likely to affect central nervous system functions (e.g. long active benzodiazepines) and lipid-lowering medications (e.g., statins)
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- Conditions which would contra-indicate MRI: implant of pacemakers or pacemaker wires; artificial heart valve; brain aneurysm surgery; middle ear implant; non-removable hearing aid or jewelry; braces; cataract surgery or lens implant; implanted mechanical or electrical device; foreign metallic objects in the body such as bullets, BBs, shrapnel, or metalwork fragments, claustrophobia;
- Current smoking;
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
This study will focus on acute effects of added sugars on brain health in a specific age group (30-64 years old). We will provide participants two meals (one meal containing 16 g of added sugars and the other containing 61 g of added sugars) and examine blood vessel function and brain structure using a MRI.
Read the detailed description
Cardiometabolic risk factors are strongly influenced by lifestyle-related environmental factors including the consumption of an unhealthy Western diet (WD). Added sugars (i.e., caloric sweeteners added to food during processing or preparation) have become a major component of the WD that are especially high in added fructose. Americans currently consume more calories from added sugars than is recommended by the American Heart Association (AHA), leading to an increased risk of cardiovascular disease (CVD), which in turn shares common risk factors with age-related memory loss and dementia. Whereas glucose is used as an immediate energy source or stored as glycogen, fructose is associated with the delayed production of triglycerides (TGs) and uric acid. Previous studies have shown that a single high-sugar meal can increase TGs in the blood 150-180 minutes after meal consumption. Increased blood TGs promote release of harmful substances that contribute to the reduction in blood vessel function and may also impact brain blood vessel function; however, these effects are not well established in humans. Our preliminary data has shown a positive association between high added sugars and plasma TG and uric acid concentration, which has been associated with reduced blood vessel function. However, the direct effects of acute added sugar intake on brain blood vessel function is currently unknown. We have also observed that high blood TGs are associated with reduced microstructural integrity of the hippocampus, a brain structure important for memory and other thinking abilities. Therefore, the purpose of this study is to establish a causal link between high added sugar consumption and reduced brain blood vessel function and microstructural integrity. We propose to examine the acute effects of high TGs and uric acid from a single high-sugar meal on brain blood vessel function and brain integrity. To test this hypothesis, we will conduct a randomized-controlled crossover trial of a high-sugar meal vs. a low-sugar meal. This project has the potential to identify future risk of dementia and other memory-related brain diseases caused from repetitive acute insults from high added sugar consumption and will help us inform the public to make better dietary choices.
- Conditions
- Healthy Diet, Healthy Aging
- Being tested
- Low Added Sugar Meal, High Added Sugar Meal
- Keywords
- added sugars, brain blood vessel function, brain structure, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Added Sugar MealOther
Consumption of a single 1,250 kcal meal containing 16 g of added sugars (5% of total energy)
High Added Sugar MealOther
Consumption of a single 1,250 kcal meal containing 61 g of added sugars (20% of total energy)
| Study group | Role | What they receive |
|---|---|---|
| Low Added Sugar Meal | Experimental | Participants will be provided a meal low in added sugars. Receives: Other: Low Added Sugar Meal |
| High Added Sugar Meal | Experimental | Participants will be provided a meal high in added sugars. Receives: Other: High Added Sugar Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cerebrovascular reactivity at 3 hours post-consumption of each meal
% change in total cerebral perfusion measured using pseudo-continuous arterial spin labeling in response to 3-minutes of hypercapnia (+9 mmHg increase in PETCO2)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in hippocampal stiffness after 3 hours post-consumption of each meal
Magnetic Resonance Elastography (MRE) of the brain to assess hippocampal viscoelastic properties while the head will be vibrated using the Resoundant acoustic driver system
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in hippocampal damping ratio at 3 hours post-consumption of each meal
Magnetic Resonance Elastography (MRE) of the brain to assess hippocampal viscoelastic properties while the head will be vibrated using the Resoundant acoustic driver system
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in uric acid at 3 hours post-consumption of each meal
Blood biomarker of uric acid (e.g. serum uric acid)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in triglycerides at 3 hours post-consumption of each meal
Blood biomarker of triglycerides (e.g. serum triglycerides)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in oxidative stress at 3 hours post-consumption of each meal
Blood biomarker of oxidative stress (e.g. superoxide)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Secondary outcomes (4)
Change from baseline in hippocampal cerebrovascular reactivity at 3 hours post-consumption of each meal
% change in total cerebral perfusion measured using pseudo-continuous arterial spin labeling in response to 3-minutes of hypercapnia (+9 mmHg increase in PETCO2)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Changes from baseline in resting cerebral blood flow at 3 hours post-consumption of each meal
Total cerebral perfusion measured using pseudo-continuous arterial spin labeling
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in other lipid profile at 3 hours post-consumption of each meal
Blood biomarkers of lipid profile (e.g. cholesterol, HDL, LDL, and VLDL)
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in blood pressure at 3 hours post-consumption of each meal
Blood pressure measures at baseline and every half hour until post-consumption of meal
Measured: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start14 Jun 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Martens, PhD, Study director, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408338
- Sponsor's protocol ID
- 1718585
- Status last verified
- May 2023
- First submitted
- 2 Jun 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Added Sugar Intake on Cerebrovascular Function and Brain Integrity
- ClinicalTrials.gov ID
- NCT05408338
- Acronym / sponsor ID
- 1718585
- Conditions
- Healthy Diet, Healthy Aging
- Keywords
- added sugars, brain blood vessel function, brain structure, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 7 Jun 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.
This study will focus on acute effects of added sugars on brain health in a specific age group (30-64 years old). We will provide participants two meals (one meal containing 16 g of added sugars and the other containing 61 g of added sugars) and examine blood vessel function and brain structure using a MRI.
Detailed description
Cardiometabolic risk factors are strongly influenced by lifestyle-related environmental factors including the consumption of an unhealthy Western diet (WD). Added sugars (i.e., caloric sweeteners added to food during processing or preparation) have become a major component of the WD that are especially high in added fructose. Americans currently consume more calories from added sugars than is recommended by the American Heart Association (AHA), leading to an increased risk of cardiovascular disease (CVD), which in turn shares common risk factors with age-related memory loss and dementia. Whereas glucose is used as an immediate energy source or stored as glycogen, fructose is associated with the delayed production of triglycerides (TGs) and uric acid. Previous studies have shown that a single high-sugar meal can increase TGs in the blood 150-180 minutes after meal consumption. Increased blood TGs promote release of harmful substances that contribute to the reduction in blood vessel function and may also impact brain blood vessel function; however, these effects are not well established in humans. Our preliminary data has shown a positive association between high added sugars and plasma TG and uric acid concentration, which has been associated with reduced blood vessel function. However, the direct effects of acute added sugar intake on brain blood vessel function is currently unknown. We have also observed that high blood TGs are associated with reduced microstructural integrity of the hippocampus, a brain structure important for memory and other thinking abilities. Therefore, the purpose of this study is to establish a causal link between high added sugar consumption and reduced brain blood vessel function and microstructural integrity. We propose to examine the acute effects of high TGs and uric acid from a single high-sugar meal on brain blood vessel function and brain integrity. To test this hypothesis, we will conduct a randomized-controlled crossover trial of a high-sugar meal vs. a low-sugar meal. This project has the potential to identify future risk of dementia and other memory-related brain diseases caused from repetitive acute insults from high added sugar consumption and will help us inform the public to make better dietary choices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Added Sugar Meal | Experimental | Other: Low Added Sugar MealParticipants will be provided a meal low in added sugars. |
| High Added Sugar Meal | Experimental | Other: High Added Sugar MealParticipants will be provided a meal high in added sugars. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to provide informed consent;
- Men and women within the ages of 30-64 years;
- Habitual added sugar intake of <150 kcal/day for men and <100kcal/day for women;
- No allergies/intolerance to ingredients in the study meal (e.g., nuts, gluten)
Key exclusion criteria (9 listed)
- Blood chemistries indicative of abnormal liver enzymes and renal function;
- Abnormal blood chemistry marker that is +/-2.5x the upper or lower limit;
- Chronic clinical diseases (e.g., coronary artery, peripheral artery, or cerebrovascular diseases, diabetes (type 1 and type 2), stages 5-6 chronic kidney disease, chronic obstructive pulmonary disease);
- Major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
- Neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct);
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 |
|---|---|---|
| Low Added Sugar MealConsumption of a single 1,250 kcal meal containing 16 g of added sugars (5% of total energy) | Other | Low Added Sugar Meal |
| High Added Sugar MealConsumption of a single 1,250 kcal meal containing 61 g of added sugars (20% of total energy) | Other | High Added Sugar Meal |
Primary outcome
Change from baseline in cerebrovascular reactivity at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
% change in total cerebral perfusion measured using pseudo-continuous arterial spin labeling in response to 3-minutes of hypercapnia (+9 mmHg increase in PETCO2)
Change from baseline in hippocampal stiffness after 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Magnetic Resonance Elastography (MRE) of the brain to assess hippocampal viscoelastic properties while the head will be vibrated using the Resoundant acoustic driver system
Change from baseline in hippocampal damping ratio at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Magnetic Resonance Elastography (MRE) of the brain to assess hippocampal viscoelastic properties while the head will be vibrated using the Resoundant acoustic driver system
Change from baseline in uric acid at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Blood biomarker of uric acid (e.g. serum uric acid)
Change from baseline in triglycerides at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Blood biomarker of triglycerides (e.g. serum triglycerides)
Change from baseline in oxidative stress at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Blood biomarker of oxidative stress (e.g. superoxide)
4 secondary outcomes
Change from baseline in hippocampal cerebrovascular reactivity at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Changes from baseline in resting cerebral blood flow at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in other lipid profile at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Change from baseline in blood pressure at 3 hours post-consumption of each meal
Time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
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 10 May 2023.
- Individual participant dataSharing planned: No
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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.
Christopher Martens, PhD study director
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Added Sugar Meal and High Added Sugar Meal in people with Healthy Diet and Healthy Aging, run by University of Delaware 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 4 inclusion and 9 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 10 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?
Change from baseline in cerebrovascular reactivity at 3 hours post-consumption of each meal (time frame: Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout). The study lists 6 primary outcomes in all. 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 10 May 2023.