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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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 ClÃnicas 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Hypocaloric diet with predominance of animal protein |
|
| Intervention | Experimental | Hypocaloric diet with predominance of plant protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin | Difference between groups in glycated hemoglobin | baseline, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Gerchman, PhD | Contact | +555133596246 | fgerchman@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Gerchman, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30487971 | Background | 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. | |
| 30660336 | Background | Willett 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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
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The participants and the care providers will not be blinded. People involved in assessing outcomes and with data analysis will be blinded.
|
| Plant-based Diet | Behavioral | 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. |
|
| 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 | 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. | 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). | 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 | baseline, 12 and 24 weeks |
| Changes in inflammatory marker | Ultra-Sensitive C-Reactive Protein (US-CRP) test will be performed to assess systemic inflammation. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | Baseline, 12 and 24 weeks |
| 9583841 | Background | Moulin 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. |
| 8137688 | Background | Tai 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. |
| 21527118 | Background | Czerwoniuk 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. |
| 24402217 | Background | Wang 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. |
| 25908249 | Background | Sousa 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. |
| 27288149 | Background | Queiroz 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. |
| 23827895 | Background | Cruz 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. |
| 42303131 | Derived | Correia 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. |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |