Type 2 DiabetesNCT05706155
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
A study testing Plant-based Diet in people with Type 2 Diabetes and Overweight, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Overweight, Obesity
- What is being tested?
- Plant-based Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 and ≤65 years old)
- Diagnosis of Type 2 Diabetes;
- Glycated hemoglobin from 7% to 11%;
- Overweight or obesity (BMI ≥25 kg/m² and <40 kg/m²);
- Use of any hypoglycemic and insulin;
- Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening;
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- Not having undergone dietary intervention in the last 6 months;
- Have the ability to understand and be able to adhere to intervention proposals;
- Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol;
Who cannot join
- Type 1 diabetes mellitus;
- Retinopathy with vision deficit that limits the activities proposed in the interventions;
- Chronic kidney disease with estimated glomerular filtration < 30 mL/min per 1.73m²;
- Liver failure, chronic viral hepatitis;
- Grade III or IV heart failure
- Active or progressive neurodegenerative disease;
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- Prior stroke that has caused sequelae;
- Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss;
- Chronic treatment with oral or parenteral corticosteroids (>7 days consecutive treatment) within 4 weeks prior to screening;
- Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening;
- Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening;
- History of active substance abuse (including alcohol) within the last year;
- Thyroid Stimulating Hormone (TSH) outside the normal range;
- Fasting triglycerides ≥ 600 mg/dL;
- Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years;
- Severe psychiatric illness;
- Predisposition or diagnosis of eating disorders;
- Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding;
- Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months;
- Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma;
- Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study;
- Night workers who work after 10pm;
- Being on a vegetarian, vegan or flexitarian diet at the time of recruitment;
- Having undergone bariatric surgery;
- Carriers of the human immunodeficiency virus (HIV);
- Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities;
- Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Fernando Gerchman, PhD, 55 51 33598127, fgerchman@hcpa.edu.br
About this study
Official title: Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial
The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.
Read the detailed description
This is a single center, open label, parallel and randomized clinical trial. Subjects with type 2 diabetes (T2D) and excessive weight will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. Patients will be also screened through electronic records of HCPA's clinics. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 24 weeks: (1) Control diet (CDG): hypocaloric diet according to current guidelines for T2D or (2) Plant-based diet (PBG): hypocaloric diet with partial replacement of animal protein by plant protein. Both groups will have caloric targets calculated to achieve a 5% weight loss during the 6 months of study, will have the same macronutrient distribution on the diet and will receive the same nutritional and medical support. Telephone calls will be performed monthly for adherence evaluation. At the end of 12 and 24 weeks of intervention, all patients will be submitted to the same clinical, laboratory and nutrition exams applied at baseline.
- Conditions
- Type 2 Diabetes, Overweight, Obesity
- Being tested
- Control Diet, Plant-based Diet
- Keywords
- Diabetes Mellitus, Obesity, Plant-based Diet, Insulin Resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control DietBehavioural
Hypocaloric diet to achieve a 5% weight loss with macronutrient distribution according to current guidelines for T2D: 50% of energy from carbohydrates, prioritizing those with low glycemic index; 30% from total fats and a maximum of 10% from saturated fats; 20% of energy from proteins, 15% from animal sources and 5% from plant sources. Participants will also receive printed and validated educational material, with recommendations for healthy eating, and will be instructed to maintain their habitual physical activity level.
Plant-based DietBehavioural
Hypocaloric diet to achieve a 5% weight loss. The dietary prescription was adapted from the Eat-Lancet Commission report to Brazilian population culture, with 50% of energy from carbohydrates, prioritizing those with a low glycemic index; 30% from total fats and a maximum of 5% from saturated fats; 20% from proteins, 5% from animal sources and 15% from plant sources. Participants in this group will receive printed and validated support material with recommendations for a healthy and plant-based eating, and will be instructed to maintain their habitual physical activity level.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Hypocaloric diet with predominance of animal protein Receives: Behavioral: Control Diet |
| Intervention | Experimental | Hypocaloric diet with predominance of plant protein Receives: Behavioral: Plant-based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin
Difference between groups in glycated hemoglobin
Measured: baseline, 12 and 24 weeks
Secondary outcomes (16)
Glycemic Variability
For continuous glucose monitoring and assessment of glycemic variability, the FreeStyle Libre, ABBOTT® device will be used. FreeStyle Libre consists of a continuous glucose monitoring (SMCG) system. Glycemic variability will be assessed using time on target parameters of values between 70 and 180 mg/dL, time in hypoglycemia and time above target and coefficient of variability as measures of glycemic variability.
Measured: baseline and 12 weeks
Changes in postprandial metabolism
Postprandial metabolism will be measured after the intake of liquid standard meal. Insulin secretion, insulin sensitivity and beta-cell function will be assessed by mathematical models
Measured: baseline and 12 weeks
Changes in body composition
Fat-free mass and fat mass will be assessed by Bioelectrical Impedance (body composition analyzer tetrapolar InBody 370S, BiospaceCo. Ltd, Seoul, South Korea). Anthropometric measures include brachial, neck, waist, hip and calf circumferences, with participants wearing light clothing and barefoot.
Measured: Monthly, up to 24 weeks
Changes in cardiometabolic outcomes
Lipid profile will include total cholesterol, HDL-c, LDL-c, triglycerides, apolipoprotein B, apolipoprotein a1 and lipoprotein (a).
Measured: baseline and 24 weeks
Changes in blood pressure
Blood pressure (mmHg) will be assessed in triplicate with an interval of 1 minute between measurements, with the participant in the sitting position, after 5 minutes of rest. On a subsample, the ambulatory blood pressure monitoring will be used in order to record blood pressure measures in 24 hours and evaluate parameters such as mean BP, pressure loads, areas under the curve, variations between daytime and nighttime, pulse pressure variability
Measured: baseline, 12 and 24 weeks
Changes in inflammatory marker
Ultra-Sensitive C-Reactive Protein (US-CRP) test will be performed to assess systemic inflammation.
Measured: baseline and 24 weeks
Changes in food craving scale
Food craving will be assessed by the Food Craving Questionnaire-State (FCQ-S), which is composed of 15 statements and is a tool sensitive to changes in contextual, psychological and physiological states in response to specific situations. Higher scores are associated with greater food deprivation, negative eating-related experiences and a greater susceptibility to triggers that lead to eating. Each item has a Likert-response, with (1) totally disagree and (5) totally agree. Total scores vary from 15 to 75 and correspond to the sum of all statements.
Measured: baseline, 12 and 24 weeks
Changes in quality of life scale
Quality of life will be measured by the The Short Form 36 Health Survey Questionnaire (the SF-36). SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Measured: baseline, 12 and 24 weeks
Changes in depressive symptoms
The Beck Depression Inventory will be used for detecting depressive symptoms, which consists of 21 sets of statements about depressive symptoms in the last 15 days that are rated on a 0 to 3 scale and total scores ranging from 0 to 63. The severity of symptoms will be classified as follows: 0-13, minimal/no depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression.
Measured: baseline, 12 and 24 weeks
Changes in anxiety symptoms
The Generalized Anxiety Symptoms-7 (GAD-7) will be used for assessing anxiety symptoms, which consists of 7 self-reported items. Each item has a Likert-response format on a 4-point scale (0- 3 points). Respondents will be asked to consider the previous 2 weeks and to rate symptom frequency as 'not at all' (0), 'several days' (1), 'more than half of all days' (2) or 'nearly all days' (3). The total score response ranges from 0 to 21.
Measured: baseline, 12 and 24 weeks
Adherence to a plant-based diet
Adherence will be assessed by 7-day weighted food records at 12 and 24 weeks, and by 24-hour food records monthly.
Measured: Baseline, 12 and 24 weeks
Incidence of sarcopenia
Incidence of sarcopenia during follow-up among participants without sarcopenia at baseline. Sarcopenia will be defined according to established diagnostic criteria, based on low handgrip strength (muscle strength), low appendicular skeletal muscle mass index (muscle quantity), and impaired physical performance assessed by the Timed Up and Go test
Measured: baseline, 12 and 24 weeks
Change in ultra-processed food consumption
Dietary intake will be assessed at baseline and follow-up and classified according to the NOVA food classification system. The outcome is the change in ultra-processed food (UPF) consumption over time. UPF intake will be quantified using complementary metrics, percentage of total energy intake (% energy), absolute energy intake (kcal/day), and amount consumed (g/day), which represent alternative expressions of the same outcome construct.
Measured: Baseline, 12, and 24 weeks
Change in estimated glomerular filtration rate
Renal function will be assessed by estimated glomerular filtration rate calculated using the CKD-EPI 2021 equation based on serum creatinine.
Measured: Baseline and 24 weeks
Change in albuminuria
Glomerular injury will be assessed by measuring urinary albumin excretion in a 24-hour urine collection and a urine sample. This analysis will be conducted in participants with urinary albumin levels greater than 14 mg/L at baseline.
Measured: Baseline, 12 and 24 weeks
Change in bone mineral metabolism parameters
Bone mineral metabolism will be assessed at baseline and follow-up. The outcome is the change in bone mineral metabolism parameters, evaluated using a panel of serum biomarkers including calcium, phosphorus, and 25-hydroxyvitamin D, measured by standard laboratory methods.
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center and open label randomized controlled trial, in which participants will be assigned to one of the two different dietary interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Fernando Gerchman, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706155
- Sponsor's protocol ID
- 2020-0095
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toumpanakis A, Turnbull T, Alba-Barba I. Effectiveness of plant-based diets in promoting well-being in the management of type 2 diabetes: a systematic review. BMJ Open Diabetes Res Care. 2018 Oct 30;6(1):e000534. doi: 10.1136/bmjdrc-2018-000534. eCollection 2018.
PubMed 30487971Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
PubMed 30660336Moulin CC, Tiskievicz F, Zelmanovitz T, de Oliveira J, Azevedo MJ, Gross JL. Use of weighed diet records in the evaluation of diets with different protein contents in patients with type 2 diabetes. Am J Clin Nutr. 1998 May;67(5):853-7. doi: 10.1093/ajcn/67.5.853.
PubMed 9583841Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152.
PubMed 8137688Czerwoniuk D, Fendler W, Walenciak L, Mlynarski W. GlyCulator: a glycemic variability calculation tool for continuous glucose monitoring data. J Diabetes Sci Technol. 2011 Mar 1;5(2):447-51. doi: 10.1177/193229681100500236.
PubMed 21527118Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
PubMed 24402217Sousa TV, Viveiros V, Chai MV, Vicente FL, Jesus G, Carnot MJ, Gordo AC, Ferreira PL. Reliability and validity of the Portuguese version of the Generalized Anxiety Disorder (GAD-7) scale. Health Qual Life Outcomes. 2015 Apr 25;13:50. doi: 10.1186/s12955-015-0244-2.
PubMed 25908249Queiroz de Medeiros AC, Campos Pedrosa LF, Hutz CS, Yamamoto ME. Brazilian version of food cravings questionnaires: Psychometric properties and sex differences. Appetite. 2016 Oct 1;105:328-33. doi: 10.1016/j.appet.2016.06.003. Epub 2016 Jun 7.
PubMed 27288149Cruz LN, Fleck MP, Oliveira MR, Camey SA, Hoffmann JF, Bagattini AM, Polanczyk CA. Health-related quality of life in Brazil: normative data for the SF-36 in a general population sample in the south of the country. Cien Saude Colet. 2013 Jul;18(7):1911-21. doi: 10.1590/s1413-81232013000700006.
PubMed 23827895Correia PE, Teixeira PP, Martins BB, Porepp OC, Kunzler LB, Natividade GR, Ferrari GT, Spiazzi BF, Colpani V, Gerchman F. Effect of partial replacement of animal protein with plant protein on glycemic control in type 2 diabetes: Rationale, design, and protocol of a randomized clinical trial. Clin Nutr ESPEN. 2026 Jun 16:103411. doi: 10.1016/j.clnesp.2026.103411. Online ahead of print.
PubMed 42303131
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05706155
- Acronym / sponsor ID
- 2020-0095
- Conditions
- Type 2 Diabetes, Overweight, Obesity
- Keywords
- Diabetes Mellitus, Obesity, Plant-based Diet, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.
Detailed description
This is a single center, open label, parallel and randomized clinical trial. Subjects with type 2 diabetes (T2D) and excessive weight will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. Patients will be also screened through electronic records of HCPA's clinics. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 24 weeks: (1) Control diet (CDG): hypocaloric diet according to current guidelines for T2D or (2) Plant-based diet (PBG): hypocaloric diet with partial replacement of animal protein by plant protein. Both groups will have caloric targets calculated to achieve a 5% weight loss during the 6 months of study, will have the same macronutrient distribution on the diet and will receive the same nutritional and medical support. Telephone calls will be performed monthly for adherence evaluation. At the end of 12 and 24 weeks of intervention, all patients will be submitted to the same clinical, laboratory and nutrition exams applied at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center and open label randomized controlled trial, in which participants will be assigned to one of the two different dietary interventions
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control DietHypocaloric diet with predominance of animal protein |
| Intervention | Experimental | Behavioral: Plant-based DietHypocaloric diet with predominance of plant protein |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (≥18 and ≤65 years old)
- Diagnosis of Type 2 Diabetes;
- Glycated hemoglobin from 7% to 11%;
- Overweight or obesity (BMI ≥25 kg/m² and <40 kg/m²);
- Use of any hypoglycemic and insulin;
Key exclusion criteria (27 listed)
- Type 1 diabetes mellitus;
- Retinopathy with vision deficit that limits the activities proposed in the interventions;
- Chronic kidney disease with estimated glomerular filtration < 30 mL/min per 1.73m²;
- Liver failure, chronic viral hepatitis;
- Grade III or IV heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control DietHypocaloric diet to achieve a 5% weight loss with macronutrient distribution according to current guidelines for T2D: 50% of energy from carbohydrates, prioritizing those with low glycemic index; 30% from total fats and a maximum of 10% from saturated fats; 20% of energy from proteins, 15% from animal sources and 5% from plant sources. Participants will also receive printed and validated educational material, with recommendations for healthy eating, and will be instructed to maintain their habitual physical activity level. | Behavioural | Control |
| Plant-based DietHypocaloric diet to achieve a 5% weight loss. The dietary prescription was adapted from the Eat-Lancet Commission report to Brazilian population culture, with 50% of energy from carbohydrates, prioritizing those with a low glycemic index; 30% from total fats and a maximum of 5% from saturated fats; 20% from proteins, 5% from animal sources and 15% from plant sources. Participants in this group will receive printed and validated support material with recommendations for a healthy and plant-based eating, and will be instructed to maintain their habitual physical activity level. | Behavioural | Intervention |
Primary outcome
Change in Glycated Hemoglobin
Time frame: baseline, 12 and 24 weeks
Difference between groups in glycated hemoglobin
16 secondary outcomes
Glycemic Variability
Time frame: baseline and 12 weeks
Changes in postprandial metabolism
Time frame: baseline and 12 weeks
Changes in body composition
Time frame: Monthly, up to 24 weeks
Changes in cardiometabolic outcomes
Time frame: baseline and 24 weeks
Changes in blood pressure
Time frame: baseline, 12 and 24 weeks
Changes in inflammatory marker
Time frame: baseline and 24 weeks
Changes in food craving scale
Time frame: baseline, 12 and 24 weeks
Changes in quality of life scale
Time frame: baseline, 12 and 24 weeks
Changes in depressive symptoms
Time frame: baseline, 12 and 24 weeks
Changes in anxiety symptoms
Time frame: baseline, 12 and 24 weeks
Adherence to a plant-based diet
Time frame: Baseline, 12 and 24 weeks
Incidence of sarcopenia
Time frame: baseline, 12 and 24 weeks
Change in ultra-processed food consumption
Time frame: Baseline, 12, and 24 weeks
Change in estimated glomerular filtration rate
Time frame: Baseline and 24 weeks
Change in albuminuria
Time frame: Baseline, 12 and 24 weeks
Change in bone mineral metabolism parameters
Time frame: Baseline, 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 30487971Toumpanakis A, Turnbull T, Alba-Barba I. Effectiveness of plant-based diets in promoting well-being in the management of type 2 diabetes: a systematic review. BMJ Open Diabetes Res Care. 2018 Oct 30;6(1):e000534. doi: 10.1136/bmjdrc-2018-000534. eCollection 2018.
- Background: PubMed 30660336Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
- Background: PubMed 9583841Moulin CC, Tiskievicz F, Zelmanovitz T, de Oliveira J, Azevedo MJ, Gross JL. Use of weighed diet records in the evaluation of diets with different protein contents in patients with type 2 diabetes. Am J Clin Nutr. 1998 May;67(5):853-7. doi: 10.1093/ajcn/67.5.853.
- Background: PubMed 8137688Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152.
- Background: PubMed 21527118Czerwoniuk D, Fendler W, Walenciak L, Mlynarski W. GlyCulator: a glycemic variability calculation tool for continuous glucose monitoring data. J Diabetes Sci Technol. 2011 Mar 1;5(2):447-51. doi: 10.1177/193229681100500236.
- Background: PubMed 24402217Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
- Background: PubMed 25908249Sousa TV, Viveiros V, Chai MV, Vicente FL, Jesus G, Carnot MJ, Gordo AC, Ferreira PL. Reliability and validity of the Portuguese version of the Generalized Anxiety Disorder (GAD-7) scale. Health Qual Life Outcomes. 2015 Apr 25;13:50. doi: 10.1186/s12955-015-0244-2.
- Background: PubMed 27288149Queiroz de Medeiros AC, Campos Pedrosa LF, Hutz CS, Yamamoto ME. Brazilian version of food cravings questionnaires: Psychometric properties and sex differences. Appetite. 2016 Oct 1;105:328-33. doi: 10.1016/j.appet.2016.06.003. Epub 2016 Jun 7.
- Background: PubMed 23827895Cruz LN, Fleck MP, Oliveira MR, Camey SA, Hoffmann JF, Bagattini AM, Polanczyk CA. Health-related quality of life in Brazil: normative data for the SF-36 in a general population sample in the south of the country. Cien Saude Colet. 2013 Jul;18(7):1911-21. doi: 10.1590/s1413-81232013000700006.
- Derived from this study: PubMed 42303131Correia PE, Teixeira PP, Martins BB, Porepp OC, Kunzler LB, Natividade GR, Ferrari GT, Spiazzi BF, Colpani V, Gerchman F. Effect of partial replacement of animal protein with plant protein on glycemic control in type 2 diabetes: Rationale, design, and protocol of a randomized clinical trial. Clin Nutr ESPEN. 2026 Jun 16:103411. doi: 10.1016/j.clnesp.2026.103411. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Gerchman, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based Diet in people with Type 2 Diabetes and Overweight, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Gerchman, PhD (+555133596246, fgerchman@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (time frame: baseline, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706155, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.