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Low vs High Sugar Diet for Brain Health in Midlife Adults

N/A
Recruiting
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
153 Previous Clinical Trials
25,138 Total Patients Enrolled
2 Trials studying Aging
136 Patients Enrolled for Aging
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,864 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main aims of this exploration?

"This clinical trial will be carried out over 1.5 months, and aims to assess the effect of a low/high added sugar diet on delayed recall memory (e.g. pictures). Secondary outcomes include changes in cognitive domain (as evaluated via NIH Toolbox Flanker test), lipid profile (evaluated through relevant blood biomarkers such as cholesterol levels) and inflammation markers measured from cytokine/interleukin concentrations in the patient's bloodstream."

Answered by AI

Does this investigation include participants who are 65 and older?

"This trial has established a cut-off age of 50, with individuals under 18 unable to take part. There are 14 trials for youths and 275 studies open to participants older than 65 years old."

Answered by AI

Is it possible to enlist in this research endeavor at present?

"Affirmative. According to clinicaltrials.gov, the trial was initially published on April 1st 2022 and amended most recently on March 24th 2022. As of now, 40 individuals need to be recruited from a single medical centre."

Answered by AI

What is the current enrollment size for this investigation?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting and was initially posted on April 1st 2022; the last update being March 24th of the same year. The protocol calls for 40 participants from a single research centre."

Answered by AI

Would I be a viable candidate for this experiment?

"Seeking 40 volunteers aged between 50 and 64 who are afflicted with ageing, this trial also has a range of other requirements. These include providing informed consent; males/postmenopausal women only; daily added sugar intake ranging from 12-15% of total calories; systolic BP < 130 mmHg and diastolic BP < 90 mmHg; BMI must be less than 30 kg/m^2 and body fat % under 25 for men or 33 for women; fasting triglycerides below 150 mg/dl (< 1.7 mmol/L); total cholesterol lower than 240 mg/dl (<6.2 mmol/L);"

Answered by AI
~1 spots leftby May 2024