Acute Effects of Added Sugar Intake on Cerebrovascular Function and Brain Integrity

Healthy Aging Clinical Trial

Official title:

Acute Effects of Added Sugar Intake on Cerebrovascular Function and Brain Integrity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408338
• Other study ID #: 1718585
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: May 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Healthy Aging
• Healthy Diet

Intervention

Other:
• Low Added Sugar Meal
Consumption of a single 1,250 kcal meal containing 16 g of added sugars (5% of total energy)
• High Added Sugar Meal
Consumption of a single 1,250 kcal meal containing 61 g of added sugars (20% of total energy)

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Primary	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	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Primary	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	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Primary	Change from baseline in uric acid at 3 hours post-consumption of each meal	Blood biomarker of uric acid (e.g. serum uric acid)	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Primary	Change from baseline in triglycerides at 3 hours post-consumption of each meal	Blood biomarker of triglycerides (e.g. serum triglycerides)	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout
Primary	Change from baseline in oxidative stress at 3 hours post-consumption of each meal	Blood biomarker of oxidative stress (e.g. superoxide)	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	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)	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	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	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	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)	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	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	Over 2 weeks, at baseline and 3 hours post-consumption of each meal (low and high added sugar), separated by a 1-week washout