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Randomized Controlled Trial
. 2023 Nov 17;15(22):4822.
doi: 10.3390/nu15224822.

The Real-Life Use of a Protein-Sparing Modified Fast Diet by Nasogastric Tube (ProMoFasT) in Adults with Obesity: An Open-Label Randomized Controlled Trial

Elena Formisano  1   2 , Irene Schiavetti  3 , Raffaella Gradaschi  2 , Paolo Gardella  1 , Carlotta Romeo  1 , Livia Pisciotta  1   2 , Samir Giuseppe Sukkar  2
Affiliations
Randomized Controlled Trial

The Real-Life Use of a Protein-Sparing Modified Fast Diet by Nasogastric Tube (ProMoFasT) in Adults with Obesity: An Open-Label Randomized Controlled Trial

Elena Formisano et al. Nutrients. .

Abstract

Background: Protein-sparing modified fast (PSMF) diet is a very-low-carbohydrate ketogenic diet administered to patients with obesity, which preserves lean mass and suppresses appetite as well as continuous enteral feeding. Thus, we aim to evaluate the effect of the PSMF diet administered continuously by nasogastric tube (NGT) or orally.

Methods: Patients with a body mass index (BMI) > 34.9 kg/m2 were randomly assigned to receive a whey protein PSMF formula through NGT (ProMoFasT) or orally. Data were collected at baseline and after 150 days. The endpoints were assessed in the intention-to-treat population.

Results: We enrolled 20 patients in the ProMoFasT group and 24 in the oral group. No differences in body weight, BMI or waist circumference between the two groups were found after 150 days. At follow-up, FFM (%) and MM (%) results were higher in the ProMoFasT group than the oral group (63.1% vs. 52.9%, p = 0.012 and 45.0% vs. 36.1%, p = 0.009, respectively) and FM (kg) and FM (%) were significantly lower in the ProMoFasT group (36.9 kg vs. 44.0 kg, p = 0.033 and 37.4% vs. 44.9%, p = 0.012, respectively). Insulin levels were lower in the ProMoFasT group than the oral group at follow-up (11.8 mU/L vs. 28.0 mU/L, p = 0.001, respectively).

Conclusion: The ProMoFasT is more effective in improving body composition and glucometabolic markers than the same diet administered orally.

Keywords: VLCKD; continuous enteral feeding; protein-sparing modified fast; severe obesity; weight loss; whey protein.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The CONSORT flowchart of the study. Abbreviations: ITT: intention-to-treat; ProMoFasT: Protein-Sparing Modified Fast diet by nasogastric tube.
Figure 2
Figure 2
Comparison of the body weight between the two groups. Abbreviations: ProMoFasT: Protein-Sparing Modified Fast diet by nasogastric tube.
Figure 3
Figure 3
Comparison of the muscle mass (%) and the fat-free mass (%) between the two groups. Abbreviations: ProMoFasT: Protein-Sparing Modified Fast diet by nasogastric tube.
Figure 4
Figure 4
Comparison of the fat mass (kg) and the fat mass (%) between the two groups. Abbreviations: ProMoFasT: Protein-Sparing Modified Fast diet by nasogastric tube.
Figure 5
Figure 5
Comparison of the fasting blood insulin and HOMA-IR between the two groups. Abbreviations: HOMA-IR: homeostasis model assessment of insulin resistance; ProMoFasT: Protein-Sparing Modified Fast diet by nasogastric tube.
See this image and copyright information in PMC

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