Clinical effects of an anti-inflammatory diet in Type 2 Diabetes

Determining the clinical effects of an anti-inflammatory microbiome restoration diet (RESTORE) in patients with Type 2 Diabetes using a strictly controlled nutritional intervention study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-4wqy488

Enrollment

Registered

2026-04-06

Start date

2025-10-10

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Thirty individuals will take part in the study and will be grouped into two groups (RESTORE diet and usual diet). The RESTORE diet consists of minimally processed foods, rich in carbohydrates accessib

6.0%, BMI &gt

25 kg/m², between 20 and 65 years old, non-vegetarian/vegan and without serious comorbidities. Participants will be recruited from clinics and through institutional partnerships. After screening and c

Eligibility

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Non-vegetarian or vegan men and non-vegetarian/vegan women; non-pregnant and non-lactating; aged between 20 and 65; diagnosis of DM2 without target organ failure; glycated hemoglobin (HbA1c) between 6.0% and 12%; BMI > 25 kg/m2

Exclusion criteria

Exclusion criteria: Presence of type 1 diabetes; use of insulin or more than three glucose reducing agents; history of ketoacidosis, myocardial infarction, stroke, angina or insufficiency in the last six months; diabetic retinopathy requiring treatment; kidney or liver disease; cancer requiring treatment in the last 5 years (with the exception of non-melanoma skin cancer); severe psychiatric disorder currently uncontrolled; allergy or other inflammatory and/or endocrine conditions; severe gastrointestinal symptoms; chronic use of laxative or anti-inflammatory medications; abuse of alcohol (>7 drinks per week), tobacco (smoking or chewing); illicit drugs or marijuana; vigorous exercise >5 hours per week; allergy or intolerance to any foods or ingredients in the dietary intervention; use of probiotics, prebiotics, fiber, omega-3 fatty acids or herbal supplements (patients will be eligible two weeks after discontinuation); use of antibiotics (patients will be eligible four weeks after discontinuation)

Design outcomes

Primary

Measure	Time frame
Evaluate changes in fructosamine concentration and glycemic variability	—

Secondary

Measure	Time frame
Evaluate changes in the concentrations of fecal calprotectin, insulin, CRP, lipid profile.;Evaluate the association and interaction of changes in metabolic markers with the microbiome.	—

Countries

Contacts

Public ContactJoão Mota

Universidade Federal de Goiás

jfemota@gmail.com+55(62)32096270

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026