臨床研究等提出・公開システム

The evaluation of the effects of CAsein hydroLysate containing milk-derived peptides on Vascular function and blood pressure in subjects with Prehypertension (CALV-P study)

CALV-P study (CALV-P study)

30

Baseline clinical characteristics Variables Mean Age (year) 49 Female (n, %) 9 (3) BMI (kg/m2) 23 Office SBP (mmHg) 126 Office DBP (mmHg) 84 LDL-C (mg/dL) 115 HbA1c (%) 5.5

A total of 52 subjects were invited for the study, and 30 subjects were initially entered into the study. Among the 30 study subjects, one subject had a 7-day mean home SBP/DBP of over 150/95 mmHg, and was requested to withdraw from the study and start to take antihypertensive medication. Then, an attempt was made to enroll one of 2 substitutes into the study, but the data of the BP measured during the run-in period could not be obtained for this patient, and therefore, this subject was not included in the analyses. In addition, another subject had an episode of urinary colic and was receiving medication for urolithiasis, one subject had influenza, and one subject was taking a phenylalanine supplement, which potentially affects the blood pressure. Then, after the aforementioned subjects were excluded from the analyses, the data of a total of 26 subjects were included in the analyses of the present study. Of the 26 subjects, 13 initially received the lactotripeptide intervention, while the remaining 13 initially received the placebo intervention.

one subject had an episode of urinary colic and was receiving medication for urolithiasis, one subject had influenza,

The home SBP DBP at the end of the lactotripeptide intervention supplementation period was significantly lower than that at the end of the placebo administration period (7 day mean BP measured at the end of each intervention). The mixed linear model analysis demonstrated a significant difference in the change of the home DBP post intervention between the two interventions (p 0.04), The urinary liver type fatty acid binding protein to creatine ratio (UFABPCR) was significantly lower in at the end of the lactotripeptide supplementation period than that at the end of the placebo administration period.

This randomized, double-blind, placebo-controlled, crossover study was conducted in 26 subjects with prehypertension. The home systolic and diastolic BP at the end of the lactotripeptide supplementation period was significantly lower than that at the end of the placebo administration period (p <0.05). The mixed linear model analysis demonstrated a significant difference in the change of the home diastolic BP post-intervention period between the two interventions (p = 0.04). The urinary liver-type fatty acid

Mar. 20, 2020

Oct. 10, 2019

https://www.jstage.jst.go.jp/article/circrep/1/10/1_CR-19-0061/_article/-char/ja

No

non

https://jrct.mhlw.go.jp/latest-detail/jRCTs071180030

Tomiyama Hirofumi

Tokyo Medical University

6-7-1 Nishishinjuku, shinjyuku-ku, Tokyo

tomiyama@tokyo-med.ac.jp

Tamiyama Hirofumi

Tokyo Medical University

6-7-1 Nishishinjuku, shinjyuku-ku, Tokyo

+81-3-3342-6111

tomiyama@tokyo-med.ac.jp

Complete

Sept. 12, 2018

Interventional

randomized controlled trial

single blind

placebo control

crossover assignment

supportive care

Prehypertension (casual blood pressure = 120-139/80-89 mmHg)

Hypertension(casual blood pressure >140/90 mmHg)
Patients with cardiovascular disease
Allergy for milk
Atrial fibrillation
Current smoker
Taking food lowering blood pressure

Both

Prehypertension (casual blood pressure = 120-139/80-89 mmHg)

The effect of functional food/placebo prescribed for 8 weeks on blood pressure is examined.

blood pressure

vascular function (pulse wave velocity, pulse wave analysis, endothelial function)

+81-98-895-8016

Feb. 26, 2019

None