NCT02895867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2016

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

May 4, 2016

Last Update Submit

February 28, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1C (A1C)

    Baseline, 12 weeks and 24 weeks

Secondary Outcomes (16)

  • Change in body weight

    Baseline, 12 weeks and 24 weeks

  • Change in total cholesterol

    Baseline, 12 weeks and 24 weeks

  • Change in high-density lipoprotein (HDL)

    Baseline, 12 weeks and 24 weeks

  • Change in low-density lipoprotein (LDL)

    Baseline, 12 weeks and 24 weeks

  • Change in triglycerides

    Baseline, 12 weeks and 24 weeks

  • +11 more secondary outcomes

Study Arms (3)

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

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

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

Other: Control

Interventions

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

Full fat dairy group
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

Low fat dairy group
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

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 32520346DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Osama Hamdy, M.D., Ph.D.

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

September 12, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)