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AgingNCT05211726

The Effects of Added Sugar Intake on Brain Blood Flow and Hippocampal Function in Midlife Adults

A study testing Low Added Sugar Diet and High Added Sugar Diet in people with Aging and Healthy Diet, run by University of Delaware at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will focus on improving brain health through dietary modification of added sugars in middle aged adults (50- 64 years old). Participants will be fed two 10-day diets (one diet containing 5% of total energy from added sugars and one diet containing 25% of total energy from added sugars) and examine blood… Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Healthy Diet
What is being tested?
Low Added Sugar Diet and High Added Sugar Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
11 Jan 2022to 3 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ability to provide informed consent;
  • men and postmenopausal women aged 50-64 years;
  • habitual intake of added sugars ≤15% of total calories;
  • systolic BP < 130 mmHg; diastolic BP < 90 mmHg;
  • body mass index (BMI) <30 kg/m2 and % body fat < 25% for men and < 33% for women;
  • fasting triglycerides < 200 mg/dl (< 2.3 mmol/L);
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  • LDL cholesterol <160 mg/dl (4.14 mmol/L);
  • fasting plasma glucose <126 mg/dl (<7.0 mmol/L) and hemoglobin A1C < 6.5% at screening;
  • weight stable in the prior 6 months (≤ 2 kg weight change);
  • blood chemistries indicative of normal liver enzymes and renal function (estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) prediction equation must be >60 ml/min/1.73 m^2).

Who cannot join

  • current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3 supplement);
  • chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease requiring dialysis, neurological or autoimmune conditions affecting cognition (e.g. Alzheimer's disease or other form of dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct);
  • major psychiatric disorder (e.g. schizophrenia, bipolar disorder);
  • major depressive disorder (PHQ-9 ≥ 10);
  • current or past (i.e., last 3 months) use of anti-hypertensive or other cardiovascular-acting medications known to influence vascular function and/or arterial stiffness;
  • current medication use likely to affect central nervous system (CNS) functions (e.g. long active benzodiazepines);
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  • concussion within last 2 years and ≥ 3 lifetime concussions;
  • heavy alcohol consumption (defined by the Centers for Disease Control and Prevention and United States Department of Agriculture as ≥8 drinks/week for women and ≥15 drinks/week for men).
  • claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning;
  • recent major change in health status within previous 6 months (i.e., surgery, significant infection or illness);
  • current smoking within the past 3 months;
  • High degree of physical activity as defined by ≥ 25 leisure metabolic equivalent (MET)-hours/week, within the past 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Delaware

    Newark, Delaware, 19713

Other trials in United States

About this study

This study will focus on improving brain health through dietary modification of added sugars in middle aged adults (50- 64 years old). Participants will be fed two 10-day diets (one diet containing 5% of total energy from added sugars and one diet containing 25% of total energy from added sugars) and examine blood vessel function, hippocampus structure using a MRI, and memory performance.

Read the detailed description

Aging is the primary risk factor for Alzheimer's disease (AD) which is the most common form of dementia and among the fastest growing causes of morbidity and mortality in the United States. The risk factors for AD emerge during midlife and are similar to cardiovascular and cerebrovascular diseases. The impact of midlife peripheral vascular changes on cardiovascular risk are worsened by poor lifestyle habits, including eating a diet that contains a lot of added sugars (defined as all caloric sweeteners added to food during processing or preparation). One effect of eating a high added sugar diet is an elevation in blood triglycerides (TGs), which impairs blood vessel function by causing inflammation; however, it is not known whether eating a lot of added sugars affects the blood vessels in the brain. The purpose of this project is to determine if there is a link between added sugar intake and brain health in midlife adults. Our hypothesis is that eating excess added sugar impairs the structure and function of an area of the brain called the hippocampus by increasing plasma TGs and systemic inflammation. To test this, we will have people eat a high and low sugar diet for 10 days each (in a random order) and test how each diet affects their blood vessel function, the structure of their hippocampus, and their memory performance. We expect to show that eating a diet that contains a lot of added sugars worsens brain health compared to a diet that contains few added sugars. The data generated from this project will help us better understand risk factors for dementia and will be used to support a future grant proposal to the National Institutes of Health aimed at lowering added sugar intake in mid-life adults and individuals with mild cognitive impairment.

Conditions
Aging, Healthy Diet
Being tested
Low Added Sugar Diet, High Added Sugar Diet
Keywords
added sugars, arterial stiffness, cerebrovascular function, cognitive function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Added Sugar DietOther

    Consumption of 10 days of a diet low in added sugars (5% of total caloric intake)

  • High Added Sugar DietOther

    Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)

Study groups in NCT05211726
Study groupRoleWhat they receive
Low Added Sugar DietExperimentalSubjects will be provided with a diet that is low in added sugars.
Receives: Other: Low Added Sugar Diet
High Added Sugar DietExperimentalSubjects will be provided with a diet that is high in added sugars.
Receives: Other: High Added Sugar Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arterial Compliance (m^2 Kilopascal^-1)

    Change in cross-sectional area of the common carotid artery (assessed using ultrasound) per 1 mmHg increase in carotid artery blood pressure (assessed by applanation tonometry). A lower carotid artery compliance is indicative of stiffer elastic arteries.

    Measured: Day 10 of the diet

  2. Cerebrovascular Reactivity (Percent Increase in Cerebral Perfusion Normalized to the Increase in PETCO2

    Cerebrovascular reactivity (CVR) is the relative (percent) change in total cerebral perfusion measured using pseudo-continuous arterial spin labeling per mmHg change in end-tidal carbon dioxide (ETCO2) during a brief period of hypercapnia. Hypercapnia was induced by prospective end-tidal targeting (RespirAct, Thornhill Medical) in which a target change in end-tidal CO2 of +9 millimeters of mercury (mmHg) was set. Data were only analyzed if ETCO2 changed by at least 6.5 mmHg. All data were then normalized to the absolute change in ETCO2.

    Measured: Day 10 of the diet

  3. Hippocampal Stiffness (kPa)

    Noninvasive brain imaging using Magnetic Resonance Elastography (MRE) to estimate tissue mechanical properties. Stiffness values are derived from the propagation of shear waves delivered to the head using vibration at 50 Hertz (Hz) from an acoustic driver system (Resoundant, Inc, Rochester MN) and reflects the distribution and organization of neurons, axons, and glial cells. A higher brain stiffness indicates greater tissue integrity.

    A nonlinear inversion algorithm estimated mechanical properties in the brain from acquired MRE displacement data to map shear modulus, G = G'+iG", where G' is the storage modulus and G'' is the loss modulus. From these parameters, stiffness is calculated, μ = 2*|G|^2 / (|G|+G')

    Measured: Day 10 of the diet

  4. Hippocampal Damping Ratio (Unitless Ratio)

    Noninvasive brain imaging using Magnetic Resonance Elastography (MRE) to estimate tissue mechanical properties. Damping Ratio is derived from the propagation of shear waves delivered to the head using vibration at 50Hz from an acoustic driver system (Resoundant, Inc, Rochester MN) and reflects the relative elasticity of the brain tissue. A lower damping ratio indicates greater tissue integrity.

    A nonlinear inversion algorithm estimated mechanical properties in the brain from acquired MRE displacement data to map shear modulus, G = G'+iG", where G' is the storage modulus and G'' is the loss modulus. From these parameters, damping ratio is calculated, ξ = G"/2*G'

    Measured: Day 10 of the diet

  5. Revised Hopkins Verbal Learning Test (HVLT-R) Total Recall Memory

    The Revised Hopkins Verbal Learning Test (HVLT-R) assesses verbal learning and memory, immediate recall and delayed recall from a list of 12 words.

    Immediate recall takes place over 3 trials (out of 12 correct responses each) Total recall is the sum of trials 1-3 (out of 36 correct responses). Delayed recall takes place 20-25 minutes after trial 3 and the participant must recall the entire list of words (out of 12 correct responses).

    Measured: Day 10 of the diet

  6. Revised Brief Visuospatial Memory Test (BVMT-R) Total Recall Score

    The Revised Brief Visuospatial Memory Test (BVMT-R) assesses visuospatial memory and includes an immediate recall and delayed recall from images.

    Immediate recall takes place over 3 trials (out of 12 correct responses each) Total recall is the sum of trials 1-3 (out of 36 correct responses). Delayed recall takes place 20-25 minutes after trial 3 and the participant must recall or redraw all the images (out of 12 correct responses).

    Measured: Day 10 of the diet

  7. Seated Systolic Blood Pressure (mmHg)

    Seated systolic blood pressure taken with arm at heart level after a 10-minute rest. Results are average of triplicate measurements

    Measured: Day 10 of diet

  8. Seated Diastolic Blood Pressure (mmHg)

    Seated diastolic blood pressure taken with arm at heart level after a 10-minute rest. Results are average of triplicate measurements

    Measured: Day 10 of diet

Secondary outcomes (4)

  1. Carotid-femoral Pulse Wave Velocity (CFPWV) (m/Seconds)

    Carotid-femoral pulse wave velocity (CFPWV) assessed using applanation tonometry of the carotid artery and cuff-based assessment of the femoral pulse wave (SphygmoCor XCEL). CFPWV is calculated as the distance between the carotid and femoral pulse divided by the time-delay between pulses. A higher CFPWV is indicative of stiffer elastic arteries.

    Measured: Day 10 of the diet

  2. Pattern Comparison Processing Speed Test (Raw/Computed Score)

    National Institute of Health (NIH) Toolbox Pattern Comparison Processing Speed Test Brief, computer-based assessment of processing speed in which participants quickly determine if two visual patterns are the same or different.

    For age 50-59, raw/computed score has a mean of 41.53 and standard deviation of 19.42 based on a normative dataset (Range = 11.00 - 65.00).

    For age 60-69, raw/computed score has a mean of 39.44 and standard deviation of 16.39 based on a normative dataset (Range = 7.00 - 64.00).

    A higher score indicates a better outcome.

    Measured: Day 10 of the diet

  3. Flanker Test (Raw/Computed Score)

    Brief, standardized assessment of attention and inhibitory control, which are key components of executive function.

    For age 50-59, raw/computed score has a mean of 8.21 and standard deviation of 1.73 based on a normative dataset (Range = 3.88 - 9.74).

    For age 60-69, raw/computed score has a mean of 8.16 and standard deviation of 1.60 based on a normative dataset (Range = 3.63 - 9.59).

    A higher score indicates a better outcome.

    Measured: Day 10 of the diet

  4. Triglycerides (mg/dL)

    Blood biomarkers triglycerides in mg/dL

    Measured: Day 10 of the diet

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start11 Jan 2022
  3. Primary completion3 May 2024
  4. Study completion3 May 2024

Resources

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
Model description
A single-blind, randomized-crossover, controlled feeding study. Participants will be provided with 10-days each of a research diet containing low sugar (LS; 5% of energy from added sugars) vs. high sugar (HS; 25% of energy from added sugars) in a random order, separated by a 2-week washout.
Masking
Single blind
Who is masked
Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211726
Sponsor's protocol ID
1760500
Other IDs
P20GM113125
Status last verified
May 2024
First submitted
21 Dec 2021
Last updated
12 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low Added Sugar Diet and High Added Sugar Diet in people with Aging and Healthy Diet, 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 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 12 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Arterial Compliance (m^2 Kilopascal^-1) (time frame: Day 10 of the diet). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211726.

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 12 Jun 2025.

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