The effect of dairy consumption on metabolism and health.
Completed
- Conditions
- Insulin resistance, Type 2 Diabetes Mellitus, metabolic health.Insuline resistentie, Type 2 Diabetes Mellitus, metabole gezondheid.
- Registration Number
- NL-OMON20152
- Lead Sponsor
- Public-Private Partnership-TKI Agro & FoodProject: ‘Basisvoedingsmiddelen- en gedragsinterventies in relatie tot behoud van gezondheid’ (TKI-AF-12104)Partners deelproject ao UMCG, FrieslandCampina.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
1. Healthy male or postmenopausal female volunteer
2. Middle-aged: between 45 and 65 yrs of age
Exclusion Criteria
1. Diabetes mellitus (based on fasting glucose and HbA1c-values at screening)
2. Clinically relevant abnormalities in blood lipids (total cholesterol > 8 mmol/L, triglycerides > 6 mmol/L, LDL > 5.7 mmol/L) at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As an indicator of metabolic flexibility the change in RQ (ÄRQ) during each challenge test (OGTT and subsequent fasting) will be measured during the test day (wk 6). This parameter relates to the change in substrate oxidation (fatty acids vs. glucose).
- Secondary Outcome Measures
Name Time Method The glycemic and insulinemic response during an OGTT and subsequent fasting.<br /><br>The differences in glucose kinetics and insulin sensitivity during an OGTT between the different test periods (high and low dairy diet).<br /><br>Additional secondary outcomes include (1) blood pressure (2) uric acid, (3) micronutrient intake and status, particularly vitamin B12 status, markers of one carbon metabolism, choline metabolism, riboflavin, and tryptophan metabolism, including tryptophan-kynurenine pathway metabolites, serotonine metabolites and melatonine metabolites, (4) markers of dairy intake, (5) markers of kidney function, (6) markers of bone turnover and calcium homeostasis, (7) markers of oxidative stress, (8) markers of inflammation, and (9) gut microbiota composition and urinary excretion of microbiota fermentation products.<br>