Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D

What Was Tested

This registered not phased trial tested Peptide YY and Ghrelin for fat loss, obesity & body recomposition.

It had two arms (groups): MBdiet (experimental) and OBdiet (active comparator).

The registry classes the interventions as device, diagnostic test and other.

More on the Plan

Most of the metabolic pathways involved in PPG i.e. secretion of insulin and glucagon-like peptide-1 (GLP-1), are controlled by circadian clock genes (CG).

In acute studies, the addition of milk to carbohydrates in B, displayed greater lowering effect of glucose response after breakfast, lunch and dinner compared with other protein sources.

The investigators also hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1, PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 30 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients diagnosed with T2D \< 20 years;. BMI - 28-40 kg/m2. Men and women 30 -75 years of age inclusive. 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 month of the study and should not have crossed time zones within 2 weeks of the study.

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: type 1 diabetes or secondary forms of diabetes; patients with latent autoimmune diabetes in adults (lada); treatment with insulin.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Peptide YY study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Peptide YY group and the comparison group ran side by side rather than switching.

Being open-label, the Peptide YY study did not mask who received what.

It started in 2018-12-28 with completion listed for 2019-06-20.

It ran at 2 sites in Israel (2).

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Clock genes mRNA expression (time frame: two weeks).

It also tracked 3 secondary outcomes, for example Continuous Glucose Monitoring (CGM), HbA1c and Body Weight.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Peptide YY and Ghrelin in 60 people with fat loss, obesity & body recomposition.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Peptide YY compound page and the Ghrelin compound page, Fat loss, obesity & body recomposition research.