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

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ClinicalTrials.gov Identifier: NCT02663544
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Mario Kratz, Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Metabolic Syndrome Obesity Diabetes NAFLD Inflammation Other: Limited dairy diet Other: Low-fat dairy diet Other: Full-fat dairy diet Not Applicable

Detailed Description:

This is a randomized controlled feeding trial designed to investigate whether the consumption of a diet rich in low-fat dairy vs. full-fat dairy vs. a limited dairy diet differentially affects glucose homeostasis. The researchers will also begin an investigation into the mechanisms by which dairy may affect glucose tolerance and its determinants. The investigators will study 60 men and women with the metabolic syndrome who will consume diets differing in their type and content of dairy foods, in a parallel-design randomized controlled trial consisting of a 4-week wash-in diet period and a 12-week dietary intervention period.

Subjects will be randomized using block randomization stratified by gender and insulin resistance (low insulin resistance vs. high insulin resistance or manifest diabetes) to one of three diet groups, which they will follow for 12 weeks: the limited dairy diet, the low-fat dairy diet, or the full-fat dairy diet. During the dietary intervention, participants will be provided with specific amounts and types of dairy products by the Human Nutrition Lab (HNL) at Fred Hutchinson Cancer Research Center (FHCRC). In the limited dairy diet arm, participants will be asked not to consume any dairy, other than three servings of nonfat milk per week, which will be provided. In the two dairy diet arms, participants will be asked to consume 3.3 servings per day of either nonfat/low-fat or full-fat milk, yogurt, and cheese. Participants will be asked to consume all of the dairy products they receive, not to consume any other dairy products for 12 weeks, and to continue consuming their habitual diet ad libitum (i.e., to eat only when hungry, and to stop eating when comfortably satiated).

Prior to randomization, subjects will complete a wash-in diet period of 4 weeks during which they will be asked to consume the limited dairy diet (i.e., consume 3 servings of nonfat milk per week, and not consume any other dairy products). In the third week of the wash-in diet period, subjects will also complete their first of two 5-day controlled feeding periods (i.e., consume study dairy products alongside a provided standard American diet) to measure ad libitum energy intake. During the last week of the wash-in diet period, participants will be admitted to clinic for a baseline visit (clinic visit #1). After clinic visit #1, subjects will be randomized to one of the three study arms, as outlined above. They will follow their randomly assigned study diet for the next 12 weeks. In the second week of the main intervention period, subjects will complete their second 5-day controlled feeding period to again measure ad libitum energy intake, this time on the specific intervention diet they had been randomized to. In the last week of the 12-week diet phase, subjects will be admitted for the follow-up clinic visit (clinic visit #2). At both clinic visits, the researchers will collect fasting blood; measure body weight and height, waist and hip circumference, and blood pressure; conduct a 3-hour FS-OGTT to assess glucose tolerance, insulin sensitivity, and pancreatic beta-cell function; conduct a whole-body DEXA scan to assess body fat mass, lean mass, and body fat distribution; and an abdominal MRI scan to assess liver triglyceride content and the ratio of intra-abdominal to subcutaneous adipose tissue. Subjects will also complete five Food Frequency Questionnaires (FFQ's) and five unannounced 24-hour dietary recalls during the study to assess dietary intakes.

The primary analysis will be a per protocol analysis that will include at least 60 participants (at least 20 in each intervention arm) who comply with all study procedures per protocol. The investigators anticipate enrolling up to 72 participants to achieve this goal. In a secondary analysis, the researchers will analyze the impact of the dietary intervention on all enrolled participants, including those who dropped out, were excluded, or non-compliant with the study protocol, in an intent-to-treat (ITT) analysis that will be reported and interpreted together with the per protocol analysis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Low-fat and Full-fat Dairy Consumption on Glucose Homeostasis (DAIRY Study)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Limited dairy diet
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
Consumption of no dairy foods other than 3 servings per week of nonfat milk for 12 weeks

Experimental: Low-fat dairy diet
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
Consumption of 3.3 servings per day of low-fat milk, yogurt, and cheese for 12 weeks

Experimental: Full-fat dairy diet
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
Consumption of 3.3 servings per day of full-fat milk, yogurt, and cheese for 12 weeks




Primary Outcome Measures :
  1. Change in glucose tolerance [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by glucose area under the curve during a frequently sampled 3-hour oral glucose tolerance test (FS-OGTT).


Secondary Outcome Measures :
  1. Change in systemic insulin sensitivity [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by the Matsuda-De Fronzo Insulin Sensitivity Index based on the FS-OGTT

  2. Change in pancreatic beta-cell function [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by the insulinogenic index based on the FS-OGTT

  3. Change in the oral disposition index (oral DI) [ Time Frame: Difference between pre- and post 12-week intervention period ]
    Oral DI is the product of insulin sensitivity (Matsuda-De Fronzo index) and beta-cell function (insulinogenic index)

  4. Change in liver fat content [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by an abdominal magnetic resonance imaging (MRI) scan

  5. Change in low-grade chronic systemic inflammation-hsCRP [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by fasting plasma concentration of C-reactive protein (CRP)

  6. Change in low-grade chronic systemic inflammation-IL-6 [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by fasting plasma concentration of interleukin-6 (IL-6)


Other Outcome Measures:
  1. Change in total body fat mass [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by whole body dual-energy x-ray absorptiometry (DEXA) scan

  2. Change in abdominal fat mass [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by whole body dual-energy x-ray absorptiometry (DEXA) scan

  3. Change in abdominal subcutaneous-to-visceral fat ratio [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by abdominal magnetic resonance imaging (MRI) scan

  4. Change in body weight [ Time Frame: Difference between pre- and post 12-week intervention period ]
    Participant weight will be measured on a calibrated digital scale in kilogram (kg) while wearing a hospital gown

  5. Changes in average diurnal glucose concentrations [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured by hemoglobin A1c (HbA1c)

  6. Changes in fasting glucose concentration [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma

  7. Change in systolic blood pressure [ Time Frame: Difference between pre- and post 12-week intervention period ]
    Measured following the American Heart Association blood pressure protocol

  8. Change in diastolic blood pressure [ Time Frame: Difference between pre- and post 12-week intervention period ]
    Measured following the American Heart Association blood pressure protocol

  9. Ad libitum energy intake over 5 days [ Time Frame: Difference in energy intake during a 5-day controlled feeding period in the study wash-in period as compared to a 5-day controlled feeding period in the intervention period ]
    Assessment of energy consumed during the two 5-day ad libitum controlled feeding periods

  10. Fasting plasma total cholesterol concentration [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma

  11. Fasting plasma high-density lipoprotein (HDL) cholesterol concentration [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma

  12. Fasting plasma triglyceride concentration [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma

  13. Fasting plasma low-density lipoprotein (LDL) cholesterol concentration [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma, or calculated by the Friedewald formula

  14. Low-density lipoprotein (LDL) subclass distribution [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma

  15. Fasting plasma total adiponectin [ Time Frame: Difference between pre- and post 12-week intervention period ]
    As measured in fasting plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663544


Contacts
Contact: Gail A Cromer, MS, CN 206-667-2543 gcromer@fredhutch.org
Contact: Kelsey A Schmidt, BA 206-667-7617 kschmid2@fredhutch.org

Locations
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
University of Washington
Investigators
Principal Investigator: Mario Kratz, PhD Fred Hutchinson Cancer Research Center, Associate Member

Responsible Party: Mario Kratz, Associate Member, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02663544     History of Changes
Other Study ID Numbers: DRI2395
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized blood samples and study data may be shared with outside investigators who sign confidentiality pledges (from participants who have given written consent for the use of study specimen and data for 'other research' only).

Keywords provided by Mario Kratz, Fred Hutchinson Cancer Research Center:
Diabetes
Metabolic syndrome
Obesity
NAFLD

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases