Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise

NCT06959043 | Recruiting

• 1 other identifier: Cappesq
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the impact of a strict vegetarian diet combined with regular physical exercise and the use of probiotics on metabolic, inflammatory, and epigenetic parameters in patients with type 2 diabetes. It aims to determine the influence of these interventions on gut microbiota, glycemic control, body composition, insulin resistance, and quality of life.

Conditions

Type 2 Diabetes Mellitus (T2DM); Insulin Resistance; Inflamation; Gut Microbiomes

Keywords

Type 2 Diabetes Mellitus; Insulin Resistance; Inflamation; Metabolic Syndrome; Physical Exercise; Gut Microbiome; Plant-based Diet; Lifestyle Interventions

Outcome Measures

Primary Outcomes (8)

• Change in Body Mass Index (BMI)

  Body mass index (BMI) will be calculated from height and weight (weight in kg / height in m²) to assess the impact of the intervention on overall body weight regulation. This outcome reflects metabolic improvement and lifestyle adherence. Unit of Measure: kg/m²

  Baseline and 4 weeks post-intervention

• Change in Waist, Abdominal, and Hip Circumference

  Waist, abdominal, and hip circumferences will be measured using a standardized flexible tape method. These anthropometric parameters are indicators of central fat distribution and associated cardiometabolic risk. Measurements will follow WHO recommendations. Unit of Measure: cm

  Baseline and 4 weeks post-intervention

• Change in Waist-to-Hip Ratio (WHR)

  Waist-to-hip ratio (WHR) will be calculated by dividing waist circumference by hip circumference. This index is used to evaluate body fat distribution and the risk of metabolic disorders, particularly central obesity, in individuals with T2DM. Unit of Measure: Ratio (unitless)

  Baseline and 4 weeks post-intervention

• Change in Functional Aerobic Capacity (1-Mile Walk Test)

  Aerobic capacity will be assessed using the 1-Mile Walk Test. Participants will be instructed to walk one mile as fast as possible on a flat surface, and the time to completion will be recorded. The objective is to evaluate improvements in cardiovascular endurance following the intervention. Unit of Measure: Time in minutes

  Baseline and 4 weeks post-intervention

• Change in Functional Mobility (Up and Go Test)

  Functional mobility will be assessed using the "Up and Go" test. Participants will be timed as they rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. The test is used to detect improvements in balance, mobility, and lower-limb function in response to the intervention. Unit of Measure: Time in seconds

  Baseline and 4 weeks post-intervention

• Change in Fasting Blood Glucose

  Fasting plasma glucose will be measured after 8-12 hours of fasting by glucose-oxidase method to evaluate improvements in basal glycemic levels. The goal is to determine whether the intervention improves glucose homeostasis in patients with T2DM. Unit of Measure: mg/dL

  Baseline and 4 weeks post-intervention

• Change in Postprandial Glucose Levels

  Two-hour postprandial glucose will be measured using capillary or venous blood samples by glucose-oxidase method after a standardized meal. The goal is to evaluate improvements in glycemic response to food intake due to the intervention. Unit of Measure: mg/dL

  Baseline and 4 weeks post-intervention

• Change in Glycated Hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) levels will be measured in venous blood samples using HPLC to assess long-term glycemic control. The main hypothesis is that the combined intervention of a plant-based diet, physical exercise, and probiotics will significantly reduce HbA1c levels compared to baseline. Unit of Measure: % HbA1c

  Baseline and 4 weeks post-intervention

Secondary Outcomes (22)

• Change in Liver Enzymes (AST, ALT, GGT)

  Baseline and 4 weeks post-intervention

• Change in Standard Lipid Profile

  Baseline and 4 weeks post-intervention

• HDL Function and Lipid Profile

  Baseline and 4 weeks post-intervention

• Change in C-Reactive Protein (CRP) Levels

  Baseline and 4 weeks post-intervention

• Change in Plasma Cytokine Levels

  Baseline and 4 weeks post-intervention

Study Arms (2)

Strict Vegetarian Diet, Regular Physical Exercise, and Placebo Administration

PLACEBO COMPARATOR

Participants in this group will follow a strict vegetarian diet (SVD) combined with regular physical exercise (RPE) for four weeks. The diet will consist of plant-based foods rich in fiber and bioactive compounds, with a controlled macronutrient distribution. Physical activity will include structured aerobic and resistance exercises supervised by a physical educator. Instead of probiotic supplementation, participants will receive a placebo administered in the same manner as the probiotic group to ensure blinding.

Dietary Supplement: Placebo Administration

Strict Vegetarian Diet, Regular Physical Exercise, and Probiotic Supplementation

EXPERIMENTAL

Participants in this group will receive the same strict vegetarian diet (SVD) and regular physical exercise (RPE) as Arm 1. In addition, they will take a probiotic supplement containing a combination of four different strains, administered twice daily for four weeks. This group aims to assess the potential additional metabolic benefits of probiotic supplementation in individuals with type 2 diabetes.

Dietary Supplement: Probiotic Supplementation

Interventions

Probiotic Supplementation DIETARY_SUPPLEMENT

Participants will follow the same strict vegetarian diet and regular physical exercise as in Intervention 1. Additionally, they will receive a probiotic supplement, taken twice daily for four weeks. This aims to evaluate the metabolic impact of probiotics in type 2 diabetes.

Also known as: Probiotic

Strict Vegetarian Diet, Regular Physical Exercise, and Probiotic Supplementation

Placebo Administration DIETARY_SUPPLEMENT

Participants will follow a strictly plant-based diet rich in fiber and bioactive compounds, with controlled macronutrient distribution. Regular physical exercise includes supervised aerobic and resistance training sessions. The intervention lasts four weeks. Instead of probiotic supplementation, participants will receive a placebo, administered in the same manner as the probiotic group to maintain blinding.

Also known as: Placebo

Strict Vegetarian Diet, Regular Physical Exercise, and Placebo Administration

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a medical diagnosis of type 2 diabetes for a maximum of 5 years.
• Be omnivorous; Have a Body Mass Index (BMI) ≥ 25 kg/m2 and \< 40 kg/m2;
• Be between the ages of 45 and 70, both genders.
• Women should be in the postmenopausal stage;
• Use no more than three hypoglycemic medications in total;
• Have the availability for a four-week consecutive hospitalization at CSVN.

You may not qualify if:

• Be using insulin, anti-obesity medications, antibiotics, and/or probiotic supplements in the 2 months preceding data collection;
• Use of alcohol or tobacco;
• Have limited mobility and a previous diagnosis of cardiopulmonary diseases;
• Report current or previous (within the past two months) diarrhea during screening;
• Have liver or kidney failure and uncontrolled endocrine disorders (hypothyroidism, hypogonadism, and adrenal insufficiency);
• Have eating disorders or have undergone bariatric surgery.

Sponsors & Collaborators

• Maria Elizabeth Rossi da Silva: lead
• Clínica e Spa Vida Natural: collaborator
• Probiotical Spa: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade de São Paulo (USP)

São Paulo, São Paulo, 01246-903, Brazil

RECRUITING

Related Publications (10)

• Guasch-Ferre M, Hruby A, Toledo E, Clish CB, Martinez-Gonzalez MA, Salas-Salvado J, Hu FB. Metabolomics in Prediabetes and Diabetes: A Systematic Review and Meta-analysis. Diabetes Care. 2016 May;39(5):833-46. doi: 10.2337/dc15-2251.

  PMID: 27208380 BACKGROUND

• Nikiforova VJ, Giesbertz P, Wiemer J, Bethan B, Looser R, Liebenberg V, Ruiz Noppinger P, Daniel H, Rein D. Glyoxylate, a new marker metabolite of type 2 diabetes. J Diabetes Res. 2014;2014:685204. doi: 10.1155/2014/685204. Epub 2014 Nov 27.

  PMID: 25525609 BACKGROUND

• Koutnikova H, Genser B, Monteiro-Sepulveda M, Faurie JM, Rizkalla S, Schrezenmeir J, Clement K. Impact of bacterial probiotics on obesity, diabetes and non-alcoholic fatty liver disease related variables: a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2019 Mar 30;9(3):e017995. doi: 10.1136/bmjopen-2017-017995.

  PMID: 30928918 BACKGROUND

• Miraghajani M, Dehsoukhteh SS, Rafie N, Hamedani SG, Sabihi S, Ghiasvand R. Potential mechanisms linking probiotics to diabetes: a narrative review of the literature. Sao Paulo Med J. 2017 Mar-Apr;135(2):169-178. doi: 10.1590/1516-3180.2016.0311271216.

  PMID: 28538869 BACKGROUND

• Heppner KM, Perez-Tilve D. GLP-1 based therapeutics: simultaneously combating T2DM and obesity. Front Neurosci. 2015 Mar 20;9:92. doi: 10.3389/fnins.2015.00092. eCollection 2015.

  PMID: 25852463 BACKGROUND

• Firouzi S, Majid HA, Ismail A, Kamaruddin NA, Barakatun-Nisak MY. Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial. Eur J Nutr. 2017 Jun;56(4):1535-1550. doi: 10.1007/s00394-016-1199-8. Epub 2016 Mar 17.

  PMID: 26988693 BACKGROUND

• Hopper I, Billah B, Skiba M, Krum H. Prevention of diabetes and reduction in major cardiovascular events in studies of subjects with prediabetes: meta-analysis of randomised controlled clinical trials. Eur J Cardiovasc Prev Rehabil. 2011 Dec;18(6):813-23. doi: 10.1177/1741826711421687. Epub 2011 Aug 30.

  PMID: 21878448 BACKGROUND

• Jardine MA, Kahleova H, Levin SM, Ali Z, Trapp CB, Barnard ND. Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Adv Nutr. 2021 Dec 1;12(6):2045-2055. doi: 10.1093/advances/nmab063.

  PMID: 34113961 BACKGROUND

• Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

  PMID: 29221645 BACKGROUND

• Barnard ND, Katcher HI, Jenkins DJ, Cohen J, Turner-McGrievy G. Vegetarian and vegan diets in type 2 diabetes management. Nutr Rev. 2009 May;67(5):255-63. doi: 10.1111/j.1753-4887.2009.00198.x.

  PMID: 19386029 BACKGROUND

Related Links

• The article reviews molecular mechanisms linking obesity to insulin resistance and highlights the role of physical exercise in reducing inflammation, improving insulin signaling, and contributing to better metabolic control and overall health.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome; Motor Activity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria E. R. Silva, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria E. R. Silva, MD, PhD

CONTACT

+55 11 3061-7258; mbeth@usp.br

Edna C. Vieira, Master of Science in Nutrition

CONTACT

+55 11 98795-1544; ednavieira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: This is a double-blind, placebo-controlled, randomized clinical trial. Patients will be informed about the type of therapy they will receive at the clinic, which includes a strict vegetarian diet and regular physical exercises, as well as the importance of adhering strictly to the prescribed instructions. A total of 60 patients will be recruited, with a maximum of six participants per four-week cycle. They will be randomized and allocated to the following treatment groups: Group 1: Strict vegetarian diet (SVD) + regular physical exercise (RPE) (n=30). Group 2: SVD + RPE + administration of a probiotic pool (n=30).

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: May 6, 2025
• Study Start: November 22, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The IPD will be available at the end of the study
• Access Criteria: The information will be available with reazonable request

Locations

BR (1)