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

NCT05408338 | Completed

• 1 other identifier: 1718585
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Diet; Healthy Aging

Keywords

added sugars; brain blood vessel function; brain structure; MRI

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Change from baseline in hippocampal cerebrovascular reactivity at 3 hours post-consumption of each 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

• Changes from baseline in resting cerebral blood flow at 3 hours post-consumption of each 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

• Change from baseline in other lipid profile at 3 hours post-consumption of each 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

• Change from baseline in blood pressure at 3 hours post-consumption of each 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

Study Arms (2)

Low Added Sugar Meal

EXPERIMENTAL

Participants will be provided a meal low in added sugars.

Other: Low Added Sugar Meal

High Added Sugar Meal

EXPERIMENTAL

Participants will be provided a meal high in added sugars.

Other: High Added Sugar Meal

Interventions

Low Added Sugar Meal OTHER

Consumption of a single 1,250 kcal meal containing 16 g of added sugars (5% of total energy)

Low Added Sugar Meal

High Added Sugar Meal OTHER

Consumption of a single 1,250 kcal meal containing 61 g of added sugars (20% of total energy)

High Added Sugar Meal

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Study Officials

• Christopher Martens, PhD

  University of Delaware

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: June 14, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)