The Impact of Low-fat and Full-fat Dairy Consumption on Glucose Homeostasis (DAIRY Study)

Completed · Not applicable

Conditions studied: Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes, NAFLD, Inflammation

In brief

This randomized controlled feeding trial aims to determine whether the consumption of different amounts and types of dairy products affects blood sugar regulation and cardiometabolic health in men and women with the metabolic syndrome.

Key facts

Study ID

NCT02663544

Run by

Fred Hutchinson Cancer Center

People needed

72

Starts

2016-01-01

Expected to finish

2018-10-18

Last updated by the study team

2019-01-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metabolic syndrome (three of the following five criteria):
• Increased waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women; in all other races: ≥ 102 cm in men, ≥ 88 cm in women
• Fasting plasma triglycerides ≥ 150 mg/dL, or drug treatment for elevated triglycerides
• High-density lipoprotein (HDL)-cholesterol <40 mg/dL in males or <50 mg/dL in females, or drug treatment for reduced HDL-cholesterol
• Systolic blood pressure ≥ 135 mm Hg or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
• Fasting plasma glucose ≥ 100 mg/dL or previous diagnosis of diabetes
• Body weight within 10% of current weight over the last 6 months before starting the study
• Able to come to the FHCRC regularly to pick up food
• Able and willing to attend a study initiation meeting of \~1.5 hour duration at the FHCRC, two clinic visits of \~5 hours duration each at the University of Washington (UW) Medial Center Clinical Research Center (CRC), and two clinic visits of \~2 hours duration each at the UW Bio-Molecular Imaging Center (BMIC)
• Willing to follow the dietary regimen
• Able to provide informed consent

You may not qualify if…

• Antidiabetic medications or insulin within the last 6 months
• Uncontrolled diabetes, defined as HbA1c > 8.0%
• Allergy to milk protein
• Presence of major chronic inflammatory or autoimmune disease (with acute symptoms or CRP > 10 mg/L), or malabsorption syndromes
• Presence or history of liver disease or end-stage renal disease requiring dialysis
• Uncontrolled thyroid disease
• Inability or unwillingness to eat the provided foods
• Contraindications for MRI scan other than body size
• Intake of drugs likely to interfere with study endpoints, including corticosteroids, anabolic steroids, antiretroviral drugs, anti-psychotic drugs and immunosuppressive drugs (within 3 months of starting the study)
• Regular high-dose use of non-steroidal anti-inflammatory drugs (more than 3 times per week and more than 600 mg per day, within 3 months of starting the study)
• Presence or recent history of anemia (within 3 months of starting the study)
• History of bariatric surgery
• Participation in an intervention study or weight-loss program (within 3 months of starting the study)
• Alcohol intake > 2 drinks per day (within 12 months of starting the study)
• Use of tobacco products, eCigarettes, or recreational drugs on more than 2 days per month (within 12 months of starting the study)
• Current or recent (within 12 months of starting the study) pregnancy or breastfeeding, or intention of becoming pregnant in the next 6 months
• Fasting Triglycerides >1000mg/dL
• Any cancer other than non-melanoma skin cancer in the last 3 years
• Other significant health condition, as determined by researcher and Physician of Record, that makes the individual unfit to participate

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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