Maastricht University
Maastricht, Limburg, 6229ER, Netherlands
NCT Number: NCT07355309
Disturbances in brain insulin sensitivity are associated not only with obesity and type 2 diabetes, but also with brain aging and cognitive decline. Longitudinal studies suggest that dietary patterns, particularly those high in dairy intake, may impact brain function via the gut-brain axis. Indeed, dairy foods are known to modulate gut microbiota and may, through this pathway, not only improve brain insulin sensitivity and cognitive performance, but also mental health and appetite regulation. However, underlying mechanisms remain largely unexplored. The primary objective of this study is to evaluate, in older adults with overweight or obesity, the effects of a high-dairy food pattern (4-5 daily servings of (butter)milk, cheese, yogurt, or cottage cheese) compared to a low-dairy food pattern (≤1 serving daily) on (regional) brain vascular function and insulin sensitivity. These outcomes will be quantified using the non-invasive MRI perfusion technique Arterial Spin Labeling (ASL), which assesses cerebral blood flow (CBF) in response to intranasal insulin, a validated physiological marker of brain insulin sensitivity. Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). Exploratory analyses include conventional cardiometabolic risk markers (blood pressure, lipid and glucose metabolism), and perceivable (consumer) benefits.
Trial opening soon.
Get Notified40 year–75 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229ER, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During the high-dairy period, participants will be instructed to consume 4-5 daily servings of dairy products, including: 1-2 servings of yogurt or cottage cheese (200 mL per serving, ≤1.5% fat), 1-2 servings of milk or buttermilk (250 mL per serving, ≤1.5% fat), and 1-2 servings of cheese (20 g per serving, 20+ or 30+ reduced-fat options).
During the low-dairy control period, participants will restrict dairy intake to a maximum of one serving per day
Time frame: Change in brain insulin sensitivity (difference in CBF [mL/100 g tissue/min] before and after intranasal insulin) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Cerebral blood flow measurements before and after a nasal insulin spray as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Time frame: Change in brain vascular function (CBF in mL/100 g tissue/min) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Time frame: Change in cognitive performance (test-specific standardized scores) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Change in gut microbial composition (shannon index indicating α-diversity) using gene relative abundance profiles at the start and end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Shotgun metagenomics of fecal samples
Time frame: Change in appetite-related brain reward activity (functional connectivity [BOLD signal changes]) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Appetite-related brain reward activity will be assessed by blood oxygenation level-dependent (BOLD) functional MRI responses to standardized food cues
Time frame: Change in blood pressure (in mmHg) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Office blood pressure
Time frame: Change in heart rate (in beats/min) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Heart rate
Time frame: Change in circulating glucose concentrations (in mmol/L) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Circulating glucose concentrations
Time frame: Change in insulin concentrations (in mIU/L) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Circulating insulin concentrations
Time frame: Change in circulating lipid concentrations (in mmol/L) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Circulating lipid concentrations
Time frame: Change in circulating high-sensitive C-reactive protein concentrations (in mg/dl) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Circulating high-sensitive C-reactive protein concentrations
Time frame: Change in perceived hunger (in mm) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Visual analogue scale (VAS) questionnaires for hunger
Time frame: Change in perceived satiety (in mm) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Visual analogue scale (VAS) questionnaires for satiety
Time frame: Change in perceived desire to eat (in mm) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Visual analogue scale (VAS) questionnaires for desire to eat
Time frame: Change in perceived fullness (in mm) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Visual analogue scale (VAS) questionnaires for fullness
Time frame: Change in perceived quality of life (average score) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
32-item quality of life questionnaire to assess perceived quality of life
Time frame: Change in perceived mood (average score) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Affect Grid Questionnaire to assess perceived mood
Time frame: Change in perceived depression and anxiety symptoms (average scores) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Beck Depression and Anxiety Inventories to assess perceived depression and anxiety symptoms
Time frame: Change in perceived stress (average score) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Perceived Stress Scale questionnaire to assess perceived stress
Time frame: Change in perceived sleep quality (average score) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Pittsburgh Sleep Quality Index to assess perceived sleep quality
Time frame: Change in food intake at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Food Frequency Questionnaire to assess food intake over the past month
Time frame: Change in urinary calcium (mmol/24 hours) at the start and end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
24-hour urine samples for analysis of calcium concentrations
Time frame: Change in urinary urea (mmol/24 hours) at the start and end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
24-hour urine samples for analysis of urea concentrations
Contact information is provided by the study sponsor or research team.
Maastricht University Medical Center
Other
Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity
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