Clinical trial NCT02895867: Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Active malignancy
* History of recent cardiovascular event
* Having a heart pacemaker
* Enrollment in other studies that may affect study outcomes

Primary outcomes:
measure: Change in Hemoglobin A1C (A1C)
timeFrame: Baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in total cholesterol
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in high-density lipoprotein (HDL)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in low-density lipoprotein (LDL)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in triglycerides
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in fasting plasma glucose
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in body fat percentage
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in fat free mass
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Height in meters
timeFrame: Baseline
measure: Change in total body water
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in waist circumference
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in trunk fat percentage
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in visceral fat level
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in blood pressure
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in c-reactive protein level
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Osama Hamdy, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.