RBR-2b7hw6b Impact of Resveratrol on the health of individuals with type 2 Diabetes

Date of registration: 06/06/2026 ^(mm/dd/yyyy)
Last approval date : 06/06/2026 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1311-9461

• Public title:

  en

  Impact of Resveratrol on the health of individuals with type 2 Diabetes

  pt-br

  Impacto do Resveratrol na saúde de pessoas com Diabetes tipo 2

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 80089224.6.0000.5191
    Issuing authority: Plataforma Brasil
  • 8.335.986
    Issuing authority: Comitê de Ética em Pesquisa Centro Universitário Integrado de Saúde Amaury de Medeiros

Sponsors

• Primary sponsor: Universidade de Pernambuco
• Secondary sponsor:
  • Institution: Universidade de Pernambuco
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Diabetes Mellitus, Type 2

  pt-br

  Diabetes mellitus tipo 2

• General descriptors for health conditions:

  en

  C19.246 Diabetes Mellitus

  pt-br

  C19.246 Diabetes Mellitus

• Specific descriptors:

  en

  C19.246.300 Diabetes Mellitus, Type 2

  pt-br

  C19.246.300 Diabetes Mellitus Tipo 2

Interventions

• Interventions:

  en

  This was a two-arm, double-blind, randomized controlled clinical trial. A total of 94 individuals who met the eligibility criteria were probabilistically allocated to either intervention group using a random number table. Neither the researchers assessing the outcomes nor the participants were aware of the group assignment for each participant. Experimental Group: 47 individuals with type 2 diabetes mellitus received oral administration of one tablet containing 150 mg of Trans-resveratrol in a single daily dose for one hundred and eighty days. Control Group: 47 individuals with type 2 diabetes mellitus received oral administration of a placebo tablet in a single daily dose for one hundred and eighty days.

  pt-br

  Trata-se de um estudo clínico randomizado controlado de dois braços, duplo-cego. Um total de 94 pessoas que preencham os critérios de elegibilidade será alocado probabilisticamente a uma ou outro grupo de intervenção utilizando uma tabela de números aleatórios. Tanto os pesquisadores que irão avaliar os desfechos como os participantes não terão conhecimento a que grupo pertence cada participante. Grupo experimental: 47 pessoas com diabetes mellitus tipo 2 receberão a administração (via oral) de um comprimido contendo 150 mg de Trans-resveratrol em dose única diária durante cento e oitenta dias. Grupo controle: 47 pessoas com diabetes mellitus tipo 2 receberão a administração (via oral) de comprimido placebo em dose única diária durante cento e oitenta dias.

• Descriptors:

  en

  V03.175.250.500 Controlled Clinical Trial

  pt-br

  V03.175.250.500 Ensaio Clínico Controlado

  en

  E05.318.370.300 Double-Blind Method

  pt-br

  E05.318.370.300 Método Duplo-Cego

  en

  D02.455.426.559.389.150.700.725.875 Resveratrol

  pt-br

  D02.455.426.559.389.150.700.725.875 Resveratrol

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 10/01/2024 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  94	-	18 Y	59 Y

• Inclusion criteria:

  en

  Having a diagnosis of type 2 diabetes mellitus; aged between 18 and 59 years; both sexes; being on oral hypoglycemic treatment or combination therapy for at least 6 months; not undergoing any antioxidant therapy, such as vitamin supplements; having no known allergy to the components used in the treatments

  pt-br

  Possuir diagnóstico de Diabetes mellitus tipo 2; idade entre 18 e 59 anos; ambos os sexos; estar no mínimo a 6 meses em tratamento hipoglicemiante oral ou terapia combinada; não estar em nenhuma terapia antioxidante como suplementos vitamínicos; não ter alergia aos componentes presentes nos tratamentos

• Exclusion criteria:

  en

  Patients with type 1 diabetes; pregnant or lactating women; patients with severe heart disease, liver disease, or renal failure

  pt-br

  Pacientes com diabetes tipo 1; gestantes; lactantes; pacientes com cardiopatia grave, hepatopatia e insuficiência renal

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Double-blind	Randomized-controlled	2

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: An improvement in glycemic metabolism is expected, as assessed by fasting blood glucose and glycated hemoglobin (HbA1c) biochemical assays, evidenced by a significant reduction in these parameters in the treatment group compared to the control group post-intervention and/or within the resveratrol-treated group.

  pt-br

  Desfecho esperado 1: Espera-se encontrar uma melhora no metabolismo glicêmico, verificado pelo método de avaliação bioquímica da Glicemia de Jejum e Hemoglobina Glicada (HbA1c), a partir da constatação de uma redução significativa dos parâmetros do grupo de tratamento em relação ao grupo controle no pós-intervenção e/ou no intragrupo tratado com o resveratrol.

  en

  Observed outcome 1: A statistically significant reduction (p = 0.020) in glycated hemoglobin (HbA1c) was observed within the resveratrol-treated group from pre- to post-intervention, as assessed by biochemical analysis followed by statistical evaluation.

  pt-br

  Desfecho encontrado 1: Foi observada uma redução estatisticamente significativa (p=0,020) na Hemoglobina Glicada (HbA1c) do grupo tratado com resveratrol, verificado pelo método de avaliação bioquímica com posterior análise estatística, na medição pós-intervenção em relação a medição pré-intervenção.

• Secondary outcomes:

  en

  Expected outcome 2: An improvement in lipid metabolism is expected, as assessed by total cholesterol, LDL, HDL, and triglycerides biochemical assays, evidenced by a significant reduction in these parameters in the treatment group compared to the control group post-intervention and/or within the resveratrol-treated group.

  pt-br

  Desfecho esperado 2: Espera-se encontrar uma melhora no metabolismo lipídico, verificado pelo método de avaliação bioquímica de Colesterol Total, LDL, HDL e Triglicerídeos, a partir da constatação de uma redução significativa dos parâmetros do grupo de tratamento em relação ao grupo controle no pós-intervenção e/ou no intragrupo tratado com o resveratrol.

  en

  Observed outcome 2: A significant increase (p < 0.001) in triglycerides was observed in the control group compared to the resveratrol-treated group post-intervention. Additionally, a statistically significant reduction (p < 0.001) in LDL and a significant increase (p = 0.005) in HDL were observed within the resveratrol-treated group from pre- to post-intervention, as assessed by biochemical analysis followed by statistical evaluation.

  pt-br

  Desfecho encontrado 2: Foi observado um aumento significativo (p<0,001) no triglicerídeo do grupo controle em relação ao grupo tratado com resveratrol pós-intervenção, além de uma redução estatisticamente significativa (p<0,001) no LDL e um aumento significativo (p=0,005) do HDL do grupo tratado com resveratrol na medição pós-intervenção em relação a medição pré-intervenção, verificado pelo método de avaliação bioquímica com posterior análise estatística.

  en

  Expected outcome 3: A reduction in the waist-to-hip ratio (WHR) is expected, as assessed by waist and hip circumference measurements, evidenced by a significant reduction in this parameter in the treatment group compared to the control group post-intervention and/or within the resveratrol-treated group.

  pt-br

  Desfecho esperado 3: Espera-se encontrar uma redução da Relação Cintura Quadril (RCQ), verificado pela aferição das medidas da cintura e do quadril, a partir da constatação de uma redução significativa da medida do grupo de tratamento em relação ao grupo controle no pós-intervenção e/ou no intragrupo tratado com o resveratrol.

  en

  Observed outcome 3: A statistically significant reduction (p = 0.013) in the waist-to-hip ratio (WHR) was observed in the treatment group compared to the control group post-intervention. Additionally, a statistically significant reduction (p = 0.017) in WHR was observed within the resveratrol-treated group from pre- to post-intervention, as assessed by waist and hip circumference measurements followed by statistical evaluation.

  pt-br

  Desfecho encontrado 3: Foi observada uma redução estatisticamente significativa (p=0,013) na Relação Cintura Quadril (RCQ) do grupo de tratamento em relação ao grupo controle pós-intervenção, além de uma redução estatisticamente significativa (p=0,017) na RCQ do grupo tratado com resveratrol na medição pós-intervenção em relação a medição pré-intervenção, verificado pela aferição das medidas da cintura e do quadril com posterior análise estatística.

  en

  Expected outcome 4: An improvement in sleep quality is expected, as assessed by the Pittsburgh Sleep Quality Index (PSQI) global score and nocturia frequency, evidenced by a significant reduction in the index score and nocturia in the treatment group compared to the control group post-intervention and/or within the resveratrol-treated group.

  pt-br

  Desfecho esperado 4: Espera-se encontrar uma melhora na qualidade do sono, verificada pela pontuação no Índice de Qualidade de Sono de Pittsburg (PSQI) e frequência de noctúria, a partir da constatação de uma redução significativa no score do Índice e de noctúria no grupo de tratamento em relação ao grupo controle no pós-intervenção e/ou no intragrupo tratado com o resveratrol.

  en

  Observed outcome 4: A statistically significant reduction (p = 0.038) in nocturia frequency was observed in the treatment group compared to the control group post-intervention. Additionally, statistically significant reductions in sleep latency (p < 0.001), subjective sleep quality (p = 0.048), and the Pittsburgh Sleep Quality Index (PSQI) global score (p < 0.001) were observed within the resveratrol-treated group from pre- to post-intervention, as assessed by the PSQI questionnaire and nocturia frequency followed by statistical evaluation.

  pt-br

  Desfecho encontrado 4: Foi observada uma redução estatisticamente significativa (p=0,038) na frequência de noctúria do grupo de tratamento em relação ao grupo controle pós-intervenção, além de uma redução estatisticamente significativa na latência do sono (p<0,001), na qualidade subjetiva do sono (p=0,048) e no score geral do Índice de Qualidade de Sono de Pittsburg (p<0,001) no grupo tratado com resveratrol na medição pós-intervenção em relação a medição pré-intervenção, verificada pela pontuação no Índice de Qualidade de Sono de Pittsburg (PSQI) e frequência de noctúria com posterior análise estatística.

Summary Results

• Baseline char:

  en

  The study included 94 participants (47 in each group). At baseline, the groups were well-balanced, with no statistically significant differences in sociodemographic or clinical variables (p > 0.05 for all). Age (Median, IQR): Control Group (CG) = 57 (54.5-59) years; Intervention Group (IG) = 57 (54.5-59) years (p=0.647). BMI (Median, IQR): CG = 30.7 (28.4-33.3) kg/m^2; IG = 30.7 (28.8-32.7) kg/m2 (p=0.374). Diabetes Diagnosis Duration: The majority of participants in both groups had been diagnosed for more than 3 years (CG = 78.7%; IG = 66.0%; p=0.169). Fasting Glucose (Median, IQR): CG = 153 (108-210) mg/dL; IG = 143 (118-185) mg/dL (p=0.898). HbA1c (Median, IQR): CG = 7.9% (6.9-9.9); IG = 7.9% (6.7-10.3) (p=0.806). Lipid Profile and Anthropometry: No significant differences were found between groups for Total Cholesterol (p=0.489), HDL (p=0,206), LDL (p=0.214), Triglycerides (p=0.203), or Waist-to-Hip Ratio (p=0.097) at the start of the protocol.

• Participants flow:

  en

  A total of 94 participants with Type 2 Diabetes Mellitus (T2DM) were recruited and underwent the initial screening process. All 94 participants met the eligibility criteria and were randomly allocated to two arms: the Intervention Group (n=47), which received 150 mg/day of trans-resveratrol, and the Control Group (n=47), which received a placebo. The total intervention protocol lasted 180 days. For the specific analysis of sleep quality (a secondary outcome), data from 60 participants (30 in each group) were collected and analyzed at the 45-day follow-up mark. There were no dropouts or exclusions during the reported assessment period for these outcomes, resulting in 100% adherence to the analyzed protocol.

• Adverse events:

  en

  No adverse events or side effects were reported by any of the 94 participants in either group (Intervention and Control) throughout the 180-day study period. Protocol adherence was 100%, with no discontinuations due to safety concerns or clinical discomfort resulting from the administration of the capsules.

• Outcome measure:

  en

  Regarding glycemic metabolism analysis, a statistically significant reduction (p=0.020) in HbA1c was observed within the resveratrol group from pre- [7.90% (6.70% - 10.30%)] to post-intervention [7.70% (6.60% - 9.75%)], which did not occur in the control group. Regarding lipid metabolism, a significant increase (p<0.001) in triglycerides was observed in the control group [204.00 mg/dL (175.00 - 250.00 mg/dL)] compared to the resveratrol group [148.00 mg/dL (128.00 - 189.00 mg/dL)] post-intervention. Furthermore, within the resveratrol group, a significant reduction (p<0.001) in LDL was observed from pre- [104.00 mg/dL (84.50 - 139.00 mg/dL)] to post-intervention [90.00 mg/dL (61.30 - 105.00 mg/dL)], alongside a significant increase (p=0.005) in HDL from pre- [51.00 mg/dL (45.00 - 56.00 mg/dL)] to post-intervention [54.00 mg/dL (49.00 - 62.00 mg/dL)]. Regarding anthropometric profile assessments, a significant reduction (p=0.013) in WHR was observed in the resveratrol group [0.92 (0.87 - 0.97)] compared to the control group [0.97 (0.93 - 1.00)] post-intervention, as well as a significant reduction (p=0.017) in Waist-to-Hip Ratio (WHR) within the resveratrol group from pre- [0.93 (0.89 - 1.00)] to post-intervention [0.92 (0.87 - 0.97)]. Regarding sleep quality, a significant reduction (p=0.038) in nocturia frequency was observed in the resveratrol group [2 (0 - 7)] compared to the control group [4 (1 - 14)] post-intervention. Additionally, within the resveratrol group, significant reductions were observed in the scores of the categories Sleep latency (p<0.001) from pre- [1.00 (0.25 – 3.00)] to post- [1.00 (0.00 - 3.00)], Subjective sleep quality (p=0.048) from pre- [1.00 (1.00 - 1.00)] to post- [1.00 (1.00 - 1.00)], and in the PSQI global score (p<0.001) from pre- [4.00 (3.00 - 5.75)] to post-intervention [3.00 (2.00 - 4.00)].

• Results summary:

  en

  Introduction: Given the increasing prevalence of type 2 diabetes mellitus (T2DM) and the lack of curative treatments, research has focused on searching for new therapies to minimize symptoms and mitigate disease progression. Objectives: To evaluate the effect of resveratrol on the metabolic profile and sleep quality of individuals with T2DM. Methods: This was a randomized, double-blind, placebo-controlled clinical trial. Individuals aged 18 to 59 years with the disease were recruited and divided into two experimental groups: the resveratrol group and the control group, receiving once daily, for 180 days, either 150 mg of resveratrol or 150 mg of cornstarch, respectively. Anthropometric and biochemical parameters were evaluated at baseline and at 180 days of treatment, while sleep quality aspects were assessed at baseline and at 45 days using the Pittsburgh Sleep Quality Index (PSQI). Results: The results demonstrated that resveratrol supplementation promoted significant improvements in the evaluated parameters, with a reduction in HbA1c (p=0.020), waist-to-hip ratio (p=0.017), and LDL (p<0.001) in treated patients, alongside the preservation of triglyceride levels (p<0.001) and an increase in HDL (p=0.005). Furthermore, sleep quality analysis showed a reduction in the PSQI global score (p<0.001), as well as a reduction in nocturia frequency. Conclusion: Supplementation with 150 mg of resveratrol improved anthropometric and biochemical parameters, as well as sleep architecture in diabetic patients. These findings indicate that resveratrol may be a promising therapeutic agent to assist in metabolic control and sleep regulation in patients with T2DM.

Data Sharing Plan

• Data Sharing Plan:

  en

  No

Contacts

• Public contact
  • Full name: Carlos Henrique Araujo Dias
  • • Address: Av. José de Sá Maniçoba S/N, Campo Universitário
    • City: Petrolina / Brazil
    • Zip code: 56304-917
  • Phone: +55(87)999518008
  • Email: carlos.dias@univasf.edu.br
  • Affiliation: Universidade Federal do Vale do São Francisco
   
• Scientific contact
  • Full name: Carlos Henrique Araujo Dias
  • • Address: Av. José de Sá Maniçoba S/N, Campo Universitário
    • City: Petrolina / Brazil
    • Zip code: 56304-917
  • Phone: +55(87)999518008
  • Email: carlos.dias@univasf.edu.br
  • Affiliation: Universidade Federal do Vale do São Francisco
   
• Site contact
  • Full name: Carlos Henrique Araujo Dias
  • • Address: Av. José de Sá Maniçoba S/N, Campo Universitário
    • City: Petrolina / Brazil
    • Zip code: 56304-917
  • Phone: +55(87)999518008
  • Email: carlos.dias@univasf.edu.br
  • Affiliation: Universidade Federal do Vale do São Francisco
   

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