Insulin ResistanceNCT02663544
The Impact of Low-fat and Full-fat Dairy Consumption on Glucose Homeostasis (DAIRY Study)
A study testing Limited dairy diet, Low-fat dairy diet and Full-fat dairy diet in people with Insulin Resistance and Metabolic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome, Obesity
- What is being tested?
- Limited dairy diet, Low-fat dairy diet and Full-fat dairy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes, NAFLD, Inflammation
- Being tested
- Limited dairy diet, Low-fat dairy diet, Full-fat dairy diet
- Keywords
- Diabetes, Metabolic syndrome, Obesity, NAFLD
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited dairy dietOther
Consumption of no dairy foods other than 3 servings per week of nonfat milk for 12 weeks
Low-fat dairy dietOther
Consumption of 3.3 servings per day of low-fat milk, yogurt, and cheese for 12 weeks
Full-fat dairy dietOther
Consumption of 3.3 servings per day of full-fat milk, yogurt, and cheese for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Full-fat dairy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
As measured by glucose area under the curve during a frequently sampled 3-hour oral glucose tolerance test (FS-OGTT).
Measured: Difference between pre- and post 12-week intervention period
Secondary outcomes (7)
Change in systemic insulin sensitivity
As measured by the Matsuda-De Fronzo Insulin Sensitivity Index based on the FS-OGTT
Measured: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: insulinogenic index
As measured by the insulinogenic index based on the FS-OGTT
Measured: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: oral disposition index
As measured by the oral disposition index (DI), the product of insulin sensitivity (Matsuda-De Fronzo index) and beta-cell function (insulinogenic index)
Measured: Difference between pre- and post 12-week intervention period
Change in liver fat content
As measured by an abdominal magnetic resonance imaging (MRI) scan
Measured: Difference between pre- and post 12-week intervention period
Change in low-grade chronic systemic inflammation: hsCRP
As measured by fasting plasma concentration of C-reactive protein (CRP)
Measured: Difference between pre- and post 12-week intervention period
Change in low-grade chronic systemic inflammation: IL-6
As measured by fasting plasma concentration of interleukin-6 (IL-6)
Measured: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: glucose sensitivity
Glucose sensitivity, as modeled from the glucose, insulin, and c-peptide data obtained from the FS-OGTT
Measured: Difference between pre- and post 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Mario Kratz, Fred Hutchinson Cancer Center
- Investigators
- Mario Kratz, PhD, Principal investigator, Fred Hutchinson Cancer Research Center, Associate Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663544
- Sponsor's protocol ID
- DRI2395
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 35294608Schmidt 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.
PubMed 34258627Schmidt 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.
PubMed 33184632
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low-fat and Full-fat Dairy Consumption on Glucose Homeostasis (DAIRY Study)
- ClinicalTrials.gov ID
- NCT02663544
- Acronym / sponsor ID
- DRI2395
- Conditions
- Insulin Resistance, Metabolic Syndrome, Obesity, Diabetes, NAFLD, Inflammation
- Keywords
- Diabetes, Metabolic syndrome, Obesity, NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Jan 2016
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Limited dairy diet | Active comparator | Other: Limited dairy dietThree 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. |
| Low-fat dairy diet | Experimental | Other: Low-fat dairy diet3.3 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. |
| Full-fat dairy diet | Experimental | Other: Full-fat dairy diet3.3 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Metabolic syndrome (three of the following five criteria):
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limited dairy dietConsumption of no dairy foods other than 3 servings per week of nonfat milk for 12 weeks | Other | Limited dairy diet |
| Low-fat dairy dietConsumption of 3.3 servings per day of low-fat milk, yogurt, and cheese for 12 weeks | Other | Low-fat dairy diet |
| Full-fat dairy dietConsumption of 3.3 servings per day of full-fat milk, yogurt, and cheese for 12 weeks | Other | Full-fat dairy diet |
Primary outcome
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).
7 secondary outcomes
Change in systemic insulin sensitivity
Time frame: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: insulinogenic index
Time frame: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: oral disposition index
Time frame: Difference between pre- and post 12-week intervention period
Change in liver fat content
Time frame: Difference between pre- and post 12-week intervention period
Change in low-grade chronic systemic inflammation: hsCRP
Time frame: Difference between pre- and post 12-week intervention period
Change in low-grade chronic systemic inflammation: IL-6
Time frame: Difference between pre- and post 12-week intervention period
Change in pancreatic beta-cell function: glucose sensitivity
Time frame: Difference between pre- and post 12-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 35294608Fernando 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.
- Derived from this study: PubMed 34258627Schmidt 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.
- Derived from this study: PubMed 33184632Schmidt 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.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Kratz, PhD principal investigator
Fred Hutchinson Cancer Research Center, Associate Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited dairy diet, Low-fat dairy diet and Full-fat dairy diet in people with Insulin Resistance and Metabolic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance (time frame: Difference between pre- and post 12-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663544, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.