Status:
COMPLETED
The Effects of Added Sugar Intake on Brain Blood Flow and Hippocampal Function in Midlife Adults
Lead Sponsor:
University of Delaware
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Aging
Healthy Diet
Eligibility:
All Genders
50-64 years
Phase:
NA
Brief 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%...
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 f...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05211726
Start Date
January 11 2022
End Date
May 3 2024
Last Update
June 12 2025
Active Locations (1)
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1
University of Delaware
Newark, Delaware, United States, 19713