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WO2018191584A1 - Compositions de suppléments nutritionnels et thérapeutiques - Google Patents

Compositions de suppléments nutritionnels et thérapeutiques Download PDF

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Publication number
WO2018191584A1
WO2018191584A1 PCT/US2018/027431 US2018027431W WO2018191584A1 WO 2018191584 A1 WO2018191584 A1 WO 2018191584A1 US 2018027431 W US2018027431 W US 2018027431W WO 2018191584 A1 WO2018191584 A1 WO 2018191584A1
Authority
WO
WIPO (PCT)
Prior art keywords
nutritional supplement
oil
supplement
protein
nutritional
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2018/027431
Other languages
English (en)
Inventor
Pankaj Jay Pasricha
Carmen ROBERTS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johns Hopkins University
Original Assignee
Johns Hopkins University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johns Hopkins University filed Critical Johns Hopkins University
Publication of WO2018191584A1 publication Critical patent/WO2018191584A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/52—Adding ingredients
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/52—Adding ingredients
    • A23L2/68—Acidifying substances
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/185—Vegetable proteins

Definitions

  • gastroparesis is a condition in which one's stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. Often, the exact cause of gastroparesis is unknown.
  • Possible causes can include uncontrolled diabetes, gastric surgery with injury to the vagus nerve, medications such as narcotics and some antidepressants, Parkinson's disease, multiple sclerosis, and rare conditions such as: amyloidosis (deposits of protein fibers in tissues and organs) and scleroderma (a connective tissue disorder that affects the skin, blood vessels, skeletal muscles, and internal organs).
  • medications such as narcotics and some antidepressants, Parkinson's disease, multiple sclerosis, and rare conditions such as: amyloidosis (deposits of protein fibers in tissues and organs) and scleroderma (a connective tissue disorder that affects the skin, blood vessels, skeletal muscles, and internal organs).
  • composition provided herein is a nutritional and therapeutic supplement with sufficient caloric content to sustain the nutritional need of a patient while triggering few or no adverse symptoms in the patient.
  • the caloric density of the nutritional and therapeutic composition is at least 2.0 kcal/ml.
  • a component in the nutritional and therapeutic supplement can comprises multiple nutrients (e.g., protein, fat, carbohydrate, and etc.).
  • one or more optional therapeutic additives are added to a nutritional and therapeutic composition disclosed herein to promote therapeutic effects, for example to overcome the symptoms of nausea, vomiting, fullness, early satiety or abdominal pain.
  • useful antiemetic agents include, but are not limited to, aprepitant, dronabinol, perphenazine, palonosetron, trimethyobenzamide, metoclopromide, domperidone, prochlorperazine, promethazine, chlorpromazine, trimethobenzamide, ondansetron, granisetron, hydroxyzine, acetylleucine monoethanolamine, alizapride, azasetron, benzquinamide, bietanautine, bromopride, buclizine, clebopride, cyclizine, dimenhydrinate, diphenidol, dolasetron, meclizine, methallatal, metopimazine, nabilone, oxyperndyl, pipamazine, scopolamine, sulpiride, tetrahydrocannabinol, thiethylperazine, thioproperazine, tropise
  • the formulation of the pharmaceutical composition and the routes and frequency of administration are determined, initially, using Phase I and Phase II clinical trials.
  • Gastroparesis is a chronic, morbid and costly neuromuscular disorder of the stomach characterized by delayed gastric emptying in the absence of gross structural abnormalities.
  • the periprandial symptoms associated with this disease can preclude adequate oral intake and often lead to weight loss and nutritional deficiencies. Intriguingly, these manifestations are partially due to impaired gastric accommodation of large volume meals and lagged transfer of mainly solid food boluses into the duodenum. Consequently, it is hypothesized that dietary supplementation with a low volume, hypercaloric, nutritional supplement as described herein can help prevent malnutrition, decrease symptom burden and improve health-related quality of life in this population. Due to the paucity of such a supplement, a novel nutritional supplement was developed specifically designed to maximize tolerability in patients with gastroparesis. The palatability of the nutritional supplement will be optimized using feedback from healthy volunteers.
  • Statistical plan including sample size justification and interim data analysis is as follows. Inferential hypothesis testing will not be performed. Descriptive statistics will be used for the analysis of the measurements obtained from the palatability questionnaire. The means and standard deviations of the answers to each item in 10 questionnaires will be determined. Safety will be determined by the incidence of adverse events in the 24-hour period following ingestion of the nutritional supplement. Adverse events will be documented using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Furthermore, the proportion of each type of adverse event and each grade of adverse event will be calculated as described in the CTCAE (version 4.0). Tolerability will be determined by calculating the mean maximum volume of the nutritional supplement that was consumed by the participants. No interim data analysis will be performed.
  • CTCAE Common Terminology Criteria for Adverse Events

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pediatric Medicine (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention concerne des compositions de suppléments nutritionnels et thérapeutiques. De telles compositions comprennent une base de fluide, un composant protéique, un composant lipidique, un composant glucidique et un ou plusieurs additifs thérapeutiques.
PCT/US2018/027431 2017-04-14 2018-04-13 Compositions de suppléments nutritionnels et thérapeutiques Ceased WO2018191584A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762485584P 2017-04-14 2017-04-14
US62/485,584 2017-04-14

Publications (1)

Publication Number Publication Date
WO2018191584A1 true WO2018191584A1 (fr) 2018-10-18

Family

ID=63793714

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/027431 Ceased WO2018191584A1 (fr) 2017-04-14 2018-04-13 Compositions de suppléments nutritionnels et thérapeutiques

Country Status (1)

Country Link
WO (1) WO2018191584A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021038563A1 (fr) * 2019-08-29 2021-03-04 Izun Pharmaceuticals Corp. Compositions de cannabis à base de protéines

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040121044A1 (en) * 2001-03-14 2004-06-24 John Tiano Nutritional product with high protein, low carbohydrate content and good physical stability
US8227013B2 (en) * 2007-06-29 2012-07-24 Vijaya Nair Dietary nutritional supplements for healthcare
WO2013028882A1 (fr) * 2011-08-25 2013-02-28 Evoke Pharma, Inc Traitement de symptômes associés à la gastroparésie chez la femme

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040121044A1 (en) * 2001-03-14 2004-06-24 John Tiano Nutritional product with high protein, low carbohydrate content and good physical stability
US8227013B2 (en) * 2007-06-29 2012-07-24 Vijaya Nair Dietary nutritional supplements for healthcare
WO2013028882A1 (fr) * 2011-08-25 2013-02-28 Evoke Pharma, Inc Traitement de symptômes associés à la gastroparésie chez la femme

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021038563A1 (fr) * 2019-08-29 2021-03-04 Izun Pharmaceuticals Corp. Compositions de cannabis à base de protéines
CN115175675A (zh) * 2019-08-29 2022-10-11 伊祖恩制药公司 基于蛋白质的大麻组合物
US12220438B2 (en) 2019-08-29 2025-02-11 Day Three Labs Manufacturing Inc. Protein based cannabis compositions

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