Understand and prevent the production of microbially-produced pro-diabetic metabolites in different ethnic groups: impact of protein dietary changes (MICRODIET)

Understand and prevent the production of microbially-produced pro-diabetic metabolites in different ethnic groups: impact of protein dietary changes (MICRODIET) - MICRODIET

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48642

Enrollment

120

Registered

2018-07-27

Start date

2018-09-24

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus suger disease

Interventions

Patients will be randomized to either a high protein or a low protein diet for three months. They will have weekly contact with an AMC dietician and will also record 3 day food diaries per week. Sub

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 40-70 years - Presence of T2D - BMI* 25kg/m2 - Use of metformin on a stable dose (i.e. no changes in the last three months) - Adequate knowledge of the Dutch language to comprehend the provided study information

Exclusion criteria

Exclusion criteria: - Use of insulin - Use of a proton-pump inhibitor - Use of antibiotics 3 months before inclusion - Vegetarian diet - Presence of inflammatory bowel disease or other chronic inflammatory disease - More than 5 units of alcohol consumption per week - Active malignancy - bariatric or other weight loss surgery in the history - patients diagnosed with eating disorders (such as bulimia nervosa, anorexia nervosa or binge-eating disorder) - HbA1c >9% (75mmol/mol) - Unmotivated or not able to adhere to a specific diet. - Estimated glomerular filtration (eGFR)

Design outcomes

Primary

Measure	Time frame
Primary objective: - Does a short term (3 months) LP diet favorably affect glucose levels after a mixed-meal test (MMT) in T2D patients of both Dutch and Caribbean descent?	—

Secondary

Measure	Time frame
Secundary objective: - Does a HP diet increase pro-diabetic metabolites, such as ImP, in T2D patients? - Do T2D patients from Dutch or Caribbean ethnicity respond differently to a HP vs LP diet intervention in terms of glucose levels after a MMT and the production of pro-diabetic metabolites, such as ImP? - Does baseline gut microbiota diversity in Caribbean subjects affect (post) prandial glucose response upon (high or low) protein diet? -Will a HP diet alter oral microbiota composition? -Will a LP diet favorably influence body weight and body composition (as measured via body impedance)? - Will a protein diet affect leukocyte methylation profiles and is this related to glucose metabolism?	—

Measure

Time frame

Secundary objective: - Does a HP diet increase pro-diabetic metabolites, such as ImP, in T2D patients? - Do T2D patients from Dutch or Caribbean ethnicity respond differently to a HP vs LP diet intervention in terms of glucose levels after a MMT and the production of pro-diabetic metabolites, such as ImP? - Does baseline gut microbiota diversity in Caribbean subjects affect (post) prandial glucose response upon (high or low) protein diet? -Will a HP diet alter oral microbiota composition? -Will a LP diet favorably influence body weight and body composition (as measured via body impedance)? - Will a protein diet affect leukocyte methylation profiles and is this related to glucose metabolism?

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)