A Clinical Study of Protein Sparing Modified Fast (PSMF) Administered Preoperatively to Morbidly Obese Patients: comparison of PSMF with natural food products to originally prepared PSMF

Kawamura, Isao; Chen, Chu Chieh; Yamazaki, Kazuma; Miyazawa, Yasumasa; Isono, Kaichi

doi:10.1381/096089292765560510

Cited by 11 publications

(14 citation statements)

References 1 publication

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“…These data are, in the short term, in agreement with previous experiences with PSMF with an elemental diet (protein 78 %, carbohydrates 19.6, fats 2.6 %) even if not completely a glucidic in a short preoperative treatment with a similar formula assumed by mouth [33]. …”

Section: Discussionsupporting

confidence: 91%

Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test)

Sukkar

Signori

Borrini

et al. 2013

Mediterr J Nutr Metab

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Anecdotal data in the last few years suggest that protein-sparing modified diet (PSMF) delivered by naso-gastric tube enteral (with continuous feeding) could attain an significant weight loss and control of appetite oral feeding, but no phase II studies on safety and efficacy have been done up to now. To verify the safety and efficacy of a protein-sparing modified fast administered by naso-gastric tube (ProMoFasT) for 10 days followed by 20 days of a low-calorie diet, in patients with morbid obesity (appetite control, fat free mass maintenance, pulmonary function tests and metabolic pattern, side effects), 26 patients with a BMI ≥30 kg/m2 have been selected. The patients had to follow a protein-sparing fast by enteral nutrition (ProMoFasT) for 24 h/day, for 10 days followed by 20 days of low-calorie diet (LCD). The endpoint was represented by body weight, BMI, abdominal circumference, Haber’s appetite test, body composition by body impedance assessment (BIA), handgrip strength test, metabolic pattern, pulmonary function test. Safety was assessed by evaluation of complications and side effects of PSMF and/or enteral nutrition. In this report the results on safety and efficacy are described after 10 and 30 days of treatment. After the recruiting phase, a total of 22 patients out of 26 enrolled [14 (63.6 %) females] were evaluated in this study. Globally almost all clinical parameters changed significantly during first 10 days. Total body weight significantly decreased after 10 days (∆−6.1 ± 2; p < 0.001) and this decrease is maintained in the following 20 days of LCD (∆ = −5.88 ± 1.79; p < 0.001). Also the abdominal circumference significantly decreased after 10 days [median (range): −4.5 (−30 to 0); p < 0.001] maintained then in the following 20 days of LCD [median (range) = −7 (−23.5 to −2); p < 0.001]. All BIA parameters significantly changed after 10 and 30 days from baseline. All parameters except BF had a significant change after 10 days of treatment while the difference at 30 days was lower than at 10 days for TBW, FFM and MM with no significant differences from baseline for the last two characteristics. For VAS appetite the difference was significant after 10 days and the decrease in appetite was maintained at 30 days with no significant difference (p = 0.83) between 10 and 30 days. No significant differences in the first 30 days were detected for PA and for both left and right hand grip strength. Particularly, a significant reduction of 1.82 kg in FFM after 10 days was detected, but not after 30 days. In contrast, a decrease of 3.8 kg of BF is observed after 30 days. As far as the respiratory functional tests (RFT) are concerned, a significant difference at 10 days was globally observed for functional residual capacity (p = 0.012) and expiratory reserve volume (p = 0.025). There are no reported major complications and side effects resulting from the enteral nutrition or PSMF. In particular, cardiac arrhythmias have not been reported. From the clinical point of view the PSMF with naso-gastric tube (ProMoFas...

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Section: Discussionsupporting

confidence: 91%

Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test)

Sukkar

Signori

Borrini

et al. 2013

Mediterr J Nutr Metab

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“…Nevertheless, a slight but statistical significant increase in uric acid was recorded with EN, as expected; gouty arthritis is reported in 1% of patients with a significant ketogenic period lasting much more than 14 days [22]. We did not record episodes of arthritis during the 14-day ketogenic period (EN).…”

Section: Discussionsupporting

confidence: 70%

“…Diet delivered by EN was therefore expected to be significantly more ketogenic than ON [19][20][21], potentially enhancing physiological mechanisms described during significant starvation [14,22]. Indeed, the difference in terms of urine ketones concentrations between EN and ON stints counter-validated our theoretical nutritional strategy.…”

Section: Discussionmentioning

confidence: 95%

Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors

Castaldo

Palmieri

Galdo

et al. 2016

Obesity Research & Clinical Practice

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“…In this scenario, alternative treatment options are warranted. About 40 years ago, after the introduction of protein-sparing modified fast (PSMF) achieved through the use of oral high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies evaluated its effectiveness and safety [ 9 , 10 ]. They showed that responsible and supervised very low-calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

“…The rationale of this treatment option rests on the following considerations: (1) VLCDs appear to be able to reduce cardiovascular risk rapidly and effectively [ 9 , 10 , 12 ]; (2) VLCDs induce considerable short- and long-term WL [ 11 ]; (3) optimal compliance with the intervention, as active participation of the patient, is not required; (4) continuous administration of the intervention formula by enteral route enables the maintenance of the body amino acid pool.…”

Section: Introductionmentioning

confidence: 99%

A 2-Week Course of Enteral Treatment with a Very Low-Calorie Protein-Based Formula for the Management of Severe Obesity

Castaldo

Monaco

Castaldo

et al. 2015

International Journal of Endocrinology

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Background. Multiple weight loss failures among obese patients suggest the design of new therapeutic strategies. We investigated the role of 2-week course of enteral treatment with a very low-calorie protein-based formula in the management of severe obesity. Methods. We evaluated the feasibility, safety, and efficacy of 2-week continuous administration of a protein-based formula (1.2 g/kg of ideal body weight/day) by nasogastric tube in severely obese adults (body mass index (BMI) ≥ 40 kg/m2). Results. In total, 364 patients (59% women; BMI = 46.6 ± 7.2 kg/m2) were recruited. The intervention was discontinued within 48 hours in 26 patients, due to nasogastric tube intolerance. No serious adverse events occurred. During the first and the second week, 65% and 80% patients, respectively, reported no side effects. All biochemical safety parameters were affected by the intervention, particularly uric acid (+45%) and aminotransferases (+48%). In the other cases the change was negligible. We observed significant weight loss (5.7 ± 2.3%) and improvement in blood pressure and glucose and lipid metabolism parameters (P < 0.001). Conclusions. A 2-week course of enteral treatment with a very low-calorie protein-based formula appeared a feasible, likely safe, and efficacious therapeutic option to be considered for inclusion into a composite weight loss program for the management of severe obesity. This trial is registered with ClinicalTrials.gov Identifier: NCT01965990.

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A Clinical Study of Protein Sparing Modified Fast (PSMF) Administered Preoperatively to Morbidly Obese Patients: comparison of PSMF with natural food products to originally prepared PSMF

Cited by 11 publications

References 1 publication

Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test)

Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test)

Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors

A 2-Week Course of Enteral Treatment with a Very Low-Calorie Protein-Based Formula for the Management of Severe Obesity

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