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An intervention study to prevent sarcopenia in hospitalized patients

An intervention study to prevent sarcopenia in hospitalized patients

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Of the 25 patients, 15 were males and 10 were females. The median age was 72 years (range: 40-84 years), HbA1c was 9.2 % (7.5-13.9 %), and muscle mass was 26.3 kg (15.6-40.2 kg).

25 patients were enrolled and underwent randomization. 12 were randomly assigned to gummy group and 13 to jelly group. One patient in gummy group and two patients in jelly group discharged before intervention. Two patients in each of gummy and jelly group discontinued the intervention. Overall, 18 patients completed the study.

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(Primary end point) (n = 18) We evaluated muscle strength changes before and after the intervention using the Wilcoxon signed-rank test. The median change in grip strength was 1.2 kg in the gummy group and 0.2 kg in the jelly group. There was no significant difference between the two groups (p = 0.757). The median in leg muscle strength change was 2.5 kg in the gummy group and 2.2 kg in the jelly group. There was no significant difference between the two groups (p = 0.596). (Secondary end points) (n = 18) We evaluated the changes in each item before and after the intervention using the Wilcoxon signed-rank test. 1) The changes in body composition and physical performance The median in skeletal muscle mass change was 0.0 kg in the gummy group and 0.0 kg in the jelly group (p = 0.690). The median in body fat mass change was -0.6 kg for the gummy group and -0.4 kg for the jelly group (p = 0.269). The median in physical performance change was 0.0 for the gummy group and 0.0 for the jelly group. There was no significant difference between the two groups (p = 0.792). 2) The changes in chewing ability and anabolic hormones for muscle growth The median in chewing ability change was 0.0 in the gummy group and 0.0 in the jelly group (p = 0.374). The median in GH change was 0.18 ng/ml in the gummy group and -0.04 ng/ml in the jelly group. The median in IGF-1 change was 9.0 ng/ml in the gummy group and 5.0 ng/ml in the jelly group. The median in DHEAS change was -3.0 microgram/dl in the gummy group and 1.0 microgram/dl in the jelly group (p = 0.145, 0.757, and 0.092, respectively). 3) The changes in blood glucose and insulin secretion The median in blood glucose change was -25.0 mg/dl in the gummy group and 2.5 mg/dl in the jelly group (p = 0.021). The median in C-peptide change was -0.12 ng/ml in the gummy group and 0.08 ng/ml in the jelly group (p = 0.093). 4) The changes in amino acids The median in The Fisher ratio change was -0.30 for the gummy group and 0.01 for the jelly group (p = 0.251). 5) The change in lactic acid The median in lactic acid change was -0.85 mg/dl for the gummy group and -2.20 mg/dl for the jelly group. There was no significant difference between the two groups (p = 0.293). 6) The change in attentional control The median change in the Stroop test score was -20.0 in the gummy group and -21.0 in the jelly group (p = 1.000).

The median change in grip and leg muscle strength was greater in the gummy group, but the insufficient sample size failed to identify a meaningful difference. The median blood glucose decrease was larger in the gummy group, but the blood glucose level before intervention in the gummy group tended to be higher than that in the jelly group, and the blood glucose level after intervention was similar in both groups. The glucose lowering treatment was prescribed by a clinical team aiming at target glucose level.

May. 15, 2025

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nothing in particular

https://jrct.mhlw.go.jp/latest-detail/jRCTs051190108

Ikeda Kaori

Kyoto University Hospital

54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, JAPAN

krikeda@kuhp.kyoto-u.ac.jp

Okamura Emi

Kyoto University Hospital

54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, JAPAN

+81-75-751-3560

e_okamura@kuhp.kyoto-u.ac.jp

Complete

Feb. 18, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

Patients with type2 diabetes

Patients with type1 diabetes
Steroid-treated patients
Patients who received gastrectomy, pancreatectomy, or intestinal resection
Patients who is difficult to be assessed muscle strength because of neuromuscular disease
Somatostatin analog-treated patients
Patients with hypothalamus or pituitary disease
Patients who restrict protein intake because of kidney disease
Patients who have difficulty of food intake or ingestion
Patients with dementia
Patients who restrict exercise
Patients whose ADL (Activity of Daily Living) is weakened
Unsuitable patients

Both

Type2 diabetes

Arm A: take hard gummy three times daily for 1 week
Arm B: take jelly three times daily for 1 week
They also perform resistance exercise

Type2 diabetes

Decline of muscle mass during hospitalization

Body composition, physical performance, chewing ability, attentional control, anabolic hormones for muscle growth, the change of blood glucose and glucose metabolic hormone, the change of amino acids fractionation, the change of lactate

+81-75-753-4680

Jan. 20, 2020

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