Hypotensive and HbA1c reducing effect of novel dietary intervention program “COMB meal program”: Two randomized clinical trials

• Published in: Journal of functional foods 2022-11, Vol.98, p.105279, Article 105279
• Main Authors: Shobako, Naohisa, Goto, Chiharu, Nakagawa, Takashi, Yamato, Tsuyoshi, Kondo, Sumio, Nakamura, Futoshi, Nakazeko, Takuo, Hirano, Yukio, Honda, Keiko
• Format: Article
• Language: English
• Subjects: Complete nutrition; Diet treatment; Open-label trial; Randomized control trial
• ISSN: 1756-4646; 2214-9414
• DOI: 10.1016/j.jff.2022.105279

[Display omitted] •We performed two randomized control clinical trials for hypotensive and anti-diabetic effect of a novel intervention program using a nutritionally balanced diet “COMB meal”, which is defined by 33 types of nutrients.•The novel intervention programs for 4 weeks significantly reduced diastolic blood pressure in male with high blood pressure compared with non-intervention group.•The novel intervention programs for 4 weeks also significantly reduced HbA1c in male with high blood glucose or HbA1c compared with non-intervention group.•No serious adverse events were observed in the both trials. Both hypertension and diabetes are so-called “silent killers.” We previously demonstrated the effect of a novel diet intervention program using COMpletely Balanced meal (COMB meal) consisting of 33 nutrient types on improving multiple parameters, including blood pressure and hemoglobin A1c (HbA1c). The present study evaluated the antihypertensive and antidiabetic effects of the program in an open-label randomized control trial. Trial 1 enrolled 100 males with high blood pressure (systolic blood pressure [SBP] ≥ 130 mmHg, and/or diastolic blood pressure [DBP] ≥ 85 mmHg). Trial 2 enrolled 99 males with HbA1c levels ≥ 5.6 %. Participants assigned to the test group took COMB meals every weekday for 4 weeks, replacing two meals per day. Compared to the control group, the test group showed significantly decreased DBP (p = 0.047) and HbA1c (p = 0.039). These results indicate that the novel program based on COMB meal might improve blood pressure and glucose metabolism through both nutrient supplementation and weight loss.