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

Completed · Not applicable

Conditions studied: Aging, Healthy Diet

In brief

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.

Key facts

Study ID

NCT05211726

Run by

University of Delaware

People needed

44

Starts

2022-01-11

Expected to finish

2024-05-03

Last updated by the study team

2025-06-12

Who can join

Age: 50 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);
• 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).

You may not qualify if…

• 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);
• 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.

Where it is running

• University of Delaware — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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