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

Official title

Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial

Overview

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.

Interventions

• Behavioral Control Diet
  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 habit
• Behavioral Plant-based Diet
  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

Primary outcome measures

• Change in Glycated Hemoglobin [Time frame: baseline, 12 and 24 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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;

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Hospital de Clínicas de Porto Alegre — Porto Alegre

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. PMID 30487971
• 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. PMID 30660336
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05706155 · 2020-0095

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗