Effect of Milk Consumption on Glycemia and Gut Microbiome in T2D

NCT05294861 | Unknown DMC

• 1 other identifier: 0041-22-WOMC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing. Indeed, in T2D, a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and of overall glycemia versus reverse schedule or six meals, with energy and carbohydrates (CH) evenly distributed throughout the day. in addition to meal timing of Bdiet, the source of protein i.e., Milk and dairy products, by favorable changes in the Guts Microbiome (GM) composition may also play a role in the reduction of overall glycemia of T2D. The investigators hypothesize that Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), will reduce overall glycemia in T2D, compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet). Study Design: The effect of the two Bdiet interventions on GM will be assessed in T2D participants in a cross-over design, at baseline and after YesMdiet and after NoMdiet, in random order. We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.

Conditions

Type2Diabetes

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome

  Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of YesMdiet

  14 day

Secondary Outcomes (2)

• Gut Microbiome

  14 days

• Overall Glycemia

  14 days

Study Arms (2)

YesMdiet

EXPERIMENTAL

After one week baseline, the participants will be assigned to YesMdiet, consuming milk and dairy products for 14 days

Other: YesMdiet

NoMdiet

ACTIVE COMPARATOR

After one week baseline, the participants will be assigned to NoMdiet, consuming another source of protein and without milk or dairy products for 14 days

Other: NoMdiet

Interventions

YesMdiet OTHER

In the YesMdiet, participants will consume Milk and Dairy products

Also known as: Yes Milk diet

YesMdiet

NoMdiet OTHER

In the YesMdiet, participants will not consume Milk and Dairy products, only other sources of protein

Also known as: No Milk diet

NoMdiet

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with T2D \< 20 years
• HbA1c ≥ 6.5 %.
• BMI - 28-45 kg/m2
• Men and women 30 -75 years of age inclusive
• Normal liver, kidney, and thyroid functions, and eGFR \> 45 mL/min/1.73 m2.
• Type 2 diabetes controlled with diet, lifestyle alone, or with antidiabetics other than insulin (i.e. biguanides, sulfonylureas, glinides, SGLT2 inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months before entering the study.
• Stable weight (less than 5% change in body weight in last 3 months before the study - determined by self-reporting or documentation in clinical records).
• Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed also on a stable dose for at least 3 months before the beginning of the trial.
• Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00 and 24:00.
• Should not have shift work within 6 months of the study and should not have crossed time zones within 2 weeks of the study.
• No change in medication or nutrition supplements or physical activity will be made during the study.

You may not qualify if:

• Type 1 diabetes or secondary forms of diabetes.
• Patients with latent autoimmune diabetes in adults (LADA).
• Treatment with insulin.
• Serum creatinine level \>2mg/dl. Renal dysfunction: eGFR \< 45 mL/min/1.73 m2).
• Hepatic dysfunction: liver disease or transaminase levels \> 2.5-fold above normal.
• Major illness with life expectancy \< 5 years.
• Malignant neoplasm requiring chemotherapy, surgery, radiation, or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer).
• Those taking psychotropic, anorectic medication, steroid treatment, or illicit drug abuse or alcoholism within one year prior to study onset. Pregnancy or lactation.
• Known hypersensitivity to milk components or lactose intolerance.
• Night or rotating shift workers or those who crossed more than 2 time zones during the 2- week period prior to study onset.
• Not able to give informed consent

Sponsors & Collaborators

• Tel Aviv University: lead

Study Officials

• Daniela Jakubowicz, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Wainstein, MD

CONTACT

972-506296940; julio_w@walla.com

Orit Twito, MD

CONTACT

972-542270104; orit.twito@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Daniela Jakubowicz, MD

Model Details: In a crossover design, the effects of YesMdiet and of NoMdiet on overall glycemia and Gut Microbiome will be assessed in the participants in random order

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 24, 2022
• Study Start: April 28, 2022
• Primary Completion: October 28, 2022
• Study Completion: December 28, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share