Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management

NCT05706155 | Recruiting

• 1 other identifier: 2020-0095
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes; Overweight; Obesity

Keywords

Diabetes Mellitus; Obesity; Plant-based Diet; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin

  Difference between groups in glycated hemoglobin

  baseline, 12 and 24 weeks

Secondary Outcomes (16)

• Glycemic Variability

  baseline and 12 weeks

• Changes in postprandial metabolism

  baseline and 12 weeks

• Changes in body composition

  Monthly, up to 24 weeks

• Changes in cardiometabolic outcomes

  baseline and 24 weeks

• Changes in blood pressure

  baseline, 12 and 24 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Hypocaloric diet with predominance of animal protein

Behavioral: Control Diet

Intervention

EXPERIMENTAL

Hypocaloric diet with predominance of plant protein

Behavioral: Plant-based Diet

Interventions

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.

Control

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (9)

• 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.

  PMID: 30487971 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.

  PMID: 30660336 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.

  PMID: 9583841 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.

  PMID: 8137688 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.

  PMID: 21527118 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.

  PMID: 24402217 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.

  PMID: 25908249 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.

  PMID: 27288149 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.

  PMID: 23827895 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Diabetes Mellitus; Insulin Resistance

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fernando Gerchman, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Gerchman, PhD

CONTACT

+555133596246; fgerchman@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants and the care providers will not be blinded. People involved in assessing outcomes and with data analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 31, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)