Type 2 DiabetesNCT02895867
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
A study testing Full fat dairy and Low fat dairy in people with Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Full fat dairy and Low fat dairy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Aug 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
- Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
- A1C ≥7 %
- Consuming <3 servings of dairy products per day
- On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
- Body weight is within 10% of current weight over the last 6 months before starting the study
Who cannot join
- Pregnancy or lactation
- Lactose intolerance
- Allergy to milk or any of its components
- Use of orlistat
- History of pancreatitis
- History of gastric bypass surgery or sleeve gastrectomy
Show all 10Show fewer
- Active malignancy
- History of recent cardiovascular event
- Having a heart pacemaker
- Enrollment in other studies that may affect study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.
Read the detailed description
This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:
Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.
- Conditions
- Type 2 Diabetes
- Being tested
- Full fat dairy, Low fat dairy, Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full fat dairyOther
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Low fat dairyOther
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
ControlOther
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
| Study group | Role | What they receive |
|---|---|---|
| Full fat dairy group | Experimental | Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of full fat dairy products into their diet Receives: Other: Full fat dairy |
| Low fat dairy group | Experimental | Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of low fat dairy products into their diet Receives: Other: Low fat dairy |
| Control group | Other | Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (A1C)
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (16)
Change in body weight
Measured: Baseline, 12 weeks and 24 weeks
Change in total cholesterol
Measured: Baseline, 12 weeks and 24 weeks
Change in high-density lipoprotein (HDL)
Measured: Baseline, 12 weeks and 24 weeks
Change in low-density lipoprotein (LDL)
Measured: Baseline, 12 weeks and 24 weeks
Change in triglycerides
Measured: Baseline, 12 weeks and 24 weeks
Change in fasting plasma glucose
Measured: Baseline, 12 weeks and 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
Measured: Baseline, 12 weeks and 24 weeks
Change in body fat percentage
Measured: Baseline, 12 weeks and 24 weeks
Change in fat free mass
Measured: Baseline, 12 weeks and 24 weeks
Height in meters
Used in calculation of Body Mass Index
Measured: Baseline
Change in total body water
Measured: Baseline, 12 weeks and 24 weeks
Change in waist circumference
Measured: Baseline, 12 weeks and 24 weeks
Change in trunk fat percentage
Measured: Baseline, 12 weeks and 24 weeks
Change in visceral fat level
Measured: Baseline, 12 weeks and 24 weeks
Change in blood pressure
Measured: Baseline, 12 weeks and 24 weeks
Change in c-reactive protein level
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Hamdy, M.D., Ph.D., Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895867
- Sponsor's protocol ID
- 2016-04
- Status last verified
- May 2026
- First submitted
- 4 May 2016
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mitri J, Tomah S, Mottalib A, Salsberg V, Ashrafzadeh S, Pober DM, Eldib AH, Tasabehji MW, Hamdy O. Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study. Am J Clin Nutr. 2020 Aug 1;112(2):293-302. doi: 10.1093/ajcn/nqaa138.
PubMed 32520346
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02895867
- Acronym / sponsor ID
- 2016-04
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Sep 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 is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.
Detailed description
This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:
Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full fat dairy group | Experimental | Other: Full fat dairyParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of full fat dairy products into their diet |
| Low fat dairy group | Experimental | Other: Low fat dairyParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of low fat dairy products into their diet |
| Control group | Other | Other: ControlParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
- A1C ≥7 %
- Consuming <3 servings of dairy products per day
- On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
- Body weight is within 10% of current weight over the last 6 months before starting the study
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- Lactose intolerance
- Allergy to milk or any of its components
- Use of orlistat
- History of pancreatitis
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 |
|---|---|---|
| Full fat dairyParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet | Other | Full fat dairy group |
| Low fat dairyParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet | Other | Low fat dairy group |
| ControlParticipants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products | Other | Control group |
Primary outcome
Change in Hemoglobin A1C (A1C)
Time frame: Baseline, 12 weeks and 24 weeks
16 secondary outcomes
Change in body weight
Time frame: Baseline, 12 weeks and 24 weeks
Change in total cholesterol
Time frame: Baseline, 12 weeks and 24 weeks
Change in high-density lipoprotein (HDL)
Time frame: Baseline, 12 weeks and 24 weeks
Change in low-density lipoprotein (LDL)
Time frame: Baseline, 12 weeks and 24 weeks
Change in triglycerides
Time frame: Baseline, 12 weeks and 24 weeks
Change in fasting plasma glucose
Time frame: Baseline, 12 weeks and 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
Time frame: Baseline, 12 weeks and 24 weeks
Change in body fat percentage
Time frame: Baseline, 12 weeks and 24 weeks
Change in fat free mass
Time frame: Baseline, 12 weeks and 24 weeks
Height in meters
Time frame: Baseline
Change in total body water
Time frame: Baseline, 12 weeks and 24 weeks
Change in waist circumference
Time frame: Baseline, 12 weeks and 24 weeks
Change in trunk fat percentage
Time frame: Baseline, 12 weeks and 24 weeks
Change in visceral fat level
Time frame: Baseline, 12 weeks and 24 weeks
Change in blood pressure
Time frame: Baseline, 12 weeks and 24 weeks
Change in c-reactive protein level
Time frame: Baseline, 12 weeks and 24 weeks
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 28 May 2026.
- Derived from this study: PubMed 32520346Mitri J, Tomah S, Mottalib A, Salsberg V, Ashrafzadeh S, Pober DM, Eldib AH, Tasabehji MW, Hamdy O. Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study. Am J Clin Nutr. 2020 Aug 1;112(2):293-302. doi: 10.1093/ajcn/nqaa138.
- Individual participant dataSharing planned: No
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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.
Osama Hamdy, M.D., Ph.D. principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full fat dairy and Low fat dairy in people with Type 2 Diabetes, run by Joslin Diabetes 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 5 inclusion and 10 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 28 May 2026. 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 Hemoglobin A1C (A1C) (time frame: Baseline, 12 weeks and 24 weeks). 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 NCT02895867, which also lists 1 linked publication.
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 28 May 2026.