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

NCT02663544 | Completed

• 1 other identifier: DRI2395
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance; Metabolic Syndrome; Obesity; Diabetes; NAFLD; Inflammation

Keywords

Diabetes; Metabolic syndrome; Obesity; NAFLD

Outcome Measures

Primary Outcomes (1)

• Change in glucose tolerance

  As measured by glucose area under the curve during a frequently sampled 3-hour oral glucose tolerance test (FS-OGTT).

  Difference between pre- and post 12-week intervention period

Secondary Outcomes (7)

• Change in systemic insulin sensitivity

  Difference between pre- and post 12-week intervention period

• Change in pancreatic beta-cell function: insulinogenic index

  Difference between pre- and post 12-week intervention period

• Change in pancreatic beta-cell function: oral disposition index

  Difference between pre- and post 12-week intervention period

• Change in liver fat content

  Difference between pre- and post 12-week intervention period

• Change in low-grade chronic systemic inflammation: hsCRP

  Difference between pre- and post 12-week intervention period

Other Outcomes (24)

• Change in total body fat mass

  Difference between pre- and post 12-week intervention period

• Change in abdominal fat mass

  Difference between pre- and post 12-week intervention period

• Change in abdominal subcutaneous-to-visceral fat ratio

  Difference between pre- and post 12-week intervention period

Study Arms (3)

Limited dairy diet

ACTIVE COMPARATOR

Three 8 oz. servings per week of non-fat milk. Participants will otherwise eat their usual diet, but will be asked not to consume any dairy products not provided by the study.

Other: Limited dairy diet

Low-fat dairy diet

EXPERIMENTAL

3.3 daily servings of non-fat and low-fat dairy products in the form of fluid milk, cheese and yogurt. Participants will otherwise eat their usual diet, and will be asked not to consume any dairy products not provided by the study.

Other: Low-fat dairy diet

Full-fat dairy diet

EXPERIMENTAL

3.3 daily servings of full-fat dairy products in the form of fluid milk, cheese and yogurt. Participants will otherwise eat their usual diet, and will be asked not to consume any dairy products not provided by the study.

Other: Full-fat dairy diet

Interventions

Limited dairy diet OTHER

Consumption of no dairy foods other than 3 servings per week of nonfat milk for 12 weeks

Limited dairy diet

Low-fat dairy diet OTHER

Consumption of 3.3 servings per day of low-fat milk, yogurt, and cheese for 12 weeks

Low-fat dairy diet

Full-fat dairy diet OTHER

Consumption of 3.3 servings per day of full-fat milk, yogurt, and cheese for 12 weeks

Full-fat dairy diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• University of Washington: collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (3)

• Fernando I, Schmidt KA, Cromer G, Burhans MS, Kuzma JN, Hagman DK, Utzschneider KM, Holte S, Kraft J, Vaughan TL, Kratz M. The impact of low-fat and full-fat dairy foods on symptoms of gastroesophageal reflux disease: an exploratory analysis based on a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2815-2823. doi: 10.1007/s00394-022-02855-6. Epub 2022 Mar 16.

  PMID: 35294608 DERIVED

• Schmidt KA, Cromer G, Burhans MS, Kuzma JN, Hagman DK, Fernando I, Murray M, Utzschneider KM, Holte S, Kraft J, Kratz M. Impact of low-fat and full-fat dairy foods on fasting lipid profile and blood pressure: exploratory endpoints of a randomized controlled trial. Am J Clin Nutr. 2021 Sep 1;114(3):882-892. doi: 10.1093/ajcn/nqab131.

  PMID: 34258627 DERIVED

• Schmidt KA, Cromer G, Burhans MS, Kuzma JN, Hagman DK, Fernando I, Murray M, Utzschneider KM, Holte S, Kraft J, Kratz M. The impact of diets rich in low-fat or full-fat dairy on glucose tolerance and its determinants: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):534-547. doi: 10.1093/ajcn/nqaa301.

  PMID: 33184632 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome; Obesity; Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes

Study Officials

• Mario Kratz, PhD

  Fred Hutchinson Cancer Research Center, Associate Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Member

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)