Feasibility and preliminary biomarker responses to capsules containing green coffee extract enriched with magnesium di-malate in women with type 2 diabetes mellitus: a randomized, placebo-controlled pilot trial.
To evaluate the feasibility of a 12-week, randomized, double-blind, placebo-controlled intervention with capsules containing green coffee extract enriched with magnesium di-malate in women with type 2 diabetes mellitus, including overall adherence to capsule use and tolerability, as well as to explore preliminary between-group differences in glycemic and cardiovascular biomarkers.
This randomized, double-blind, placebo-controlled pilot trial included 48 eligible women with type 2 diabetes mellitus, equally assigned to the placebo group (n=24) or the experimental group (n=24). Participants received capsules daily for 12 weeks and were followed up through nursing consultations. Overall retention was 83.3% (40/48), and overall adherence to capsule use was estimated at over 82%. Glycemic biomarkers included fasting glucose, estimated mean glucose, HbA1c, insulin, HOMA-IR, and HOMA-β. Cardiovascular biomarkers included urea, creatinine, uric acid, apolipoprotein B, triglycerides, and the triglycerides-glucose index. Data were analyzed based on avail-able data from participants who completed follow-up and the final evaluation.
The protocol was feasible under the study conditions, although retention differed between groups. Glycemic biomarkers varied during follow-up in both groups, without conclusive evidence of a consistent between-group effect. In the experimental group, triglycerides and the triglycerides-glucose index showed numerical reductions, while uric acid fluctuated in both groups. These findings should be interpreted as exploratory.
This pilot trial provided preliminary information on the feasibility of implementing this intervention in women with type 2 diabetes mellitus. The biomarker findings were exploratory and imprecise and do not allow for definitive conclusions on efficacy.
This randomized, double-blind, placebo-controlled pilot trial included 48 eligible women with type 2 diabetes mellitus, equally assigned to the placebo group (n=24) or the experimental group (n=24). Participants received capsules daily for 12 weeks and were followed up through nursing consultations. Overall retention was 83.3% (40/48), and overall adherence to capsule use was estimated at over 82%. Glycemic biomarkers included fasting glucose, estimated mean glucose, HbA1c, insulin, HOMA-IR, and HOMA-β. Cardiovascular biomarkers included urea, creatinine, uric acid, apolipoprotein B, triglycerides, and the triglycerides-glucose index. Data were analyzed based on avail-able data from participants who completed follow-up and the final evaluation.
The protocol was feasible under the study conditions, although retention differed between groups. Glycemic biomarkers varied during follow-up in both groups, without conclusive evidence of a consistent between-group effect. In the experimental group, triglycerides and the triglycerides-glucose index showed numerical reductions, while uric acid fluctuated in both groups. These findings should be interpreted as exploratory.
This pilot trial provided preliminary information on the feasibility of implementing this intervention in women with type 2 diabetes mellitus. The biomarker findings were exploratory and imprecise and do not allow for definitive conclusions on efficacy.
Authors
Moura de Araújo Moura de Araújo, Garcia Lira Neto Garcia Lira Neto, Lima Inácio Lima Inácio, Freitas Costa Freitas Costa, Júnior Freire de Freitas Júnior Freire de Freitas, Coelho Damasceno Coelho Damasceno, do Livramento de Paula do Livramento de Paula, Costa Pereira Costa Pereira, Pinheiro Landim Almeida Pinheiro Landim Almeida, de Souza Teixeira de Souza Teixeira
View on Pubmed