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The effect of dairy consumption on metabolism and health.

The effect of dairy consumption on metabolic flexibility and glucose metabolism.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20152
Enrollment
52
Registered
2014-11-11
Start date
2014-11-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin resistance, Type 2 Diabetes Mellitus, metabolic health. Insuline resistentie, Type 2 Diabetes Mellitus, metabole gezondheid.

Interventions

High dairy (5-6 portions/day) vs low dairy (<1 portion/day), for a 6 week period each. Portion sizes are 250 ml for (butter)milk, 200 g for yoghurt and 30 g (one slice) of cheese.

Sponsors

Public-Private Partnership-TKI Agro & Food Project: ‘Basisvoedingsmiddelen- en gedragsinterventies in relatie tot behoud van gezondheid’ (TKI-AF-12104) Partners deelproject ao UMCG, FrieslandCampina.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male or postmenopausal female volunteer 2. Middle-aged: between 45 and 65 yrs of age 3. BMI > 25 to < 30 kg/m2 4. Low-medium dairy consumer (based on VCP, assessed by questionnaire on health and lifestyle) 5. Used to consume 3 main meals a day including breakfast 6. Not involved in intensive sports activities more than twice a week (e.g. playing football, tennis, running, race-cycling, swimming) 7. Stable weight and no intention to lose weight until completion of the study 8. Able to participate and willing to comply with study procedures and restrictions 9. Signed written informed consent form (ICF)

Exclusion criteria

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 3. Clinically relevant abnormalities in hematology (a.o. Hb < 8,7 mmol/L) at screening 4. Clinically relevant abnormalities in markers for liver (ALAT, ASAT) and kidney (creatinine-albumin ratio, urine) damage at screening 5. Positive HIV, HbsAg and/or HepC at screening 6. Not being able to fast overnight (12 hours) 7. Unable to resign from smoking during test day (12h) without symptoms of withdrawal 8. Gastrointestinal disorders or undergone digestive tract surgery (except appendectomy) 9. Intake of nutritional supplements (from screening until the end of the study) 10. Use of medication (from screening until the end of the study) that, in the opinion of the investigator/physician, would interfere with the study parameters: oral anti-diabetics, insulin, lipid-lowering drugs (from screening until the end of the study) and anti-biotics (from 1 month before screening). 11. Reported slimming or medically prescribed diet 12. Reported vegan, vegetarian or macrobiotic life-style

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The glycemic and insulinemic response during an OGTT and subsequent fasting. The differences in glucose kinetics and insulin sensitivity during an OGTT between the different test periods (high and low dairy diet). 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.

Contacts

Public ContactC. Eelderink
c.eelderink@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)