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Low vs High Sugar Diet for Brain Health in Midlife Adults

N/A
Waitlist Available
Led By Christopher Martens, Ph.D.
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and postmenopausal women aged 50-64 years
Blood chemistries indicative of normal liver enzymes and renal function (estimated glomerular filtration rate using the MDRD prediction equation must be >60 ml/min/1.73 m^2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 1.5 months. once at baseline and again at the end of each 10 day diet (low and high added sugar), separated by a 2 week washout period
Awards & highlights

Study Summary

This trial will improve brain health by altering diets to include less sugar for middle-aged adults. The effects will be studied by blood vessel function, hippocampus structure, and memory performance.

Who is the study for?
This trial is for non-smoking men and postmenopausal women aged 50-64 with a BMI <30, normal blood sugar and cholesterol levels, stable weight, and no major psychiatric disorders or chronic diseases. Participants should not be on certain medications that affect brain or heart function.Check my eligibility
What is being tested?
The study tests the impact of diets with different sugar levels (5% vs. 25% of total energy from added sugars) on brain health in midlife adults over two separate 10-day periods by assessing blood flow, hippocampal structure via MRI scans, and memory performance.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include changes in mood or energy due to dietary sugar variations. The high-sugar diet could potentially lead to discomfort or health issues related to increased sugar intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a postmenopausal woman aged between 50 and 64.
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My liver and kidney functions are normal.
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My BMI is under 30 and my body fat is below the recommended percentage for my gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 1.5 months. once at baseline and again at the end of each 10 day diet (low and high added sugar), separated by a 2 week washout period
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 1.5 months. once at baseline and again at the end of each 10 day diet (low and high added sugar), separated by a 2 week washout period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in arterial compliance at the end of each diet
Change from baseline in cerebrovascular reactivity at the end of each diet
Change from baseline in delayed recall memory (e.g. pictures) at the end of each diet
+4 more
Secondary outcome measures
Change from baseline in cognitive domain (e.g. inhibition) at the end of each diet
Change from baseline in cognitive domain (e.g. processing speed) at the end of each diet
Change from baseline in inflammation at the end of each diet
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Added Sugar DietExperimental Treatment1 Intervention
Subjects will be provided with a diet that is low in added sugars.
Group II: High Added Sugar DietExperimental Treatment1 Intervention
Subjects will be provided with a diet that is high in added sugars.

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
154 Previous Clinical Trials
25,050 Total Patients Enrolled
2 Trials studying Aging
136 Patients Enrolled for Aging
National Institute of General Medical Sciences (NIGMS)NIH
272 Previous Clinical Trials
246,984 Total Patients Enrolled
Christopher Martens, Ph.D.Principal InvestigatorUniversity of Delaware

Media Library

High Added Sugar Diet Clinical Trial Eligibility Overview. Trial Name: NCT05211726 — N/A
Aging Research Study Groups: Low Added Sugar Diet, High Added Sugar Diet
Aging Clinical Trial 2023: High Added Sugar Diet Highlights & Side Effects. Trial Name: NCT05211726 — N/A
High Added Sugar Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211726 — N/A
~11 spots leftby Jun 2025
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