# US 12,110,562 B2 · Compositions and methods for predicting and promoting weight loss

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- Number: US 12,110,562 B2
- Document ID: US12110562B2
- Status: Granted
- Kind: B2
- Application number: 15/992,496
- Filed: 2018-05-30
- Published: 2019-02-28
- Granted: 2024-10-08
- Earliest claimed: 2017-06-01
- Assignees: University of Copenhagen
- Applicants: University of Copenhagen
- Inventors: Mads Fiil Hjorth; Arne Vernon Astrup; Yishai Zohar
- Web page: https://patentgrep.com/patent/US12110562B2

## CPC

- C12Q 1/689: for bacteria
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23V 2200/332: Promoters of weight control and weight loss
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The invention provides methods for identifying biomarkers in a patient's microbiota to predict a patient's response to a predetermined diet to promote weight loss and methods of promoting weight loss in the patient by optimizing the patient's diet in accordance with the biomarkers identified in the patient's gut microbiota. The methods of the invention can also be used to manage or maintain weight, i.e., prevent or inhibit weight gain, in a patient who is of normal weight or is overweight or obese.

## Claims

### Claim 1

A method of promoting weight loss in a patient wherein the patient has been identified as having at least one of: (a) a gut microbiota with a relative abundance of log 10 (Prevotella spp.) of greater than −3, (b) a gut microbiota with a relative abundance of log 10 (Prevotella spp./Bacteroides spp.) of greater than −2, (c) a gut microbiota with a relative abundance of Log 10 (Prevotella spp./Bacteroidetes all) of greater than −2, and (d) a gut microbiota with a relative abundance of Log 10(Bacteroidetes all/Bacteroides spp.) of greater than 0, comprising the steps of;
(a) determining the patient's fasting plasma glucose (FPG) and fasting insulin level (FI); and
(b) administering to the patient a predetermined diet, wherein
(i) the patient's FPG is less than about 90 mg/dL, the patient's FI is below about 9.5 uU/mL and the predetermined diet is Diet 1;
(ii) the patient's FPG is less than about 90 mg/dL, the patient's FI is above about 13 uU/mL, and the predetermined diet is Diet 2;
(iii) the patient's FPG is between about 90 and 100 mg/dL, the patient's FI is above about 13 uU/mL and the predetermined diet is Diet 4;
(iv) the patient's FPG is between about 100 and 115 mg/dL, the patient's FI is below about 9.5 uU/mL and the predetermined diet is Diet 5;
(v) the patient's FPG is between about 100 and 115 mg/dL, the patient's FI is above about 13 uU/mL and the predetermined diet is Diet 6;
(vi) vi the patient's FPG is between about 115 and 125 mg/dL, the patient's FI is below about 9.5 uU/mL and the predetermined diet is Diet 7;
(vii) vii the patient's FPG is between about 115 and 125 mg/dL, the patient's FI is above about 13 uU/mL and the predetermined diet is Diet 8;
(viii) the patient's FPG is greater than about 125 mg/dL, the patient's FI is below about 9.5 uU/mL and the predetermined diet is Diet 9;
(ix) the patient's FPG is greater than about 125 mg/dL, the patient's FI is above about 13 uU/mL and the predetermined diet is Diet 10;
(x) the patient's FPG is less than about 90 mg/dL, the patient's FI is between about 9.5 to about 13 uU/mL, and the predetermined diet is Diet 1 or Diet 2;
(xi) the patient's FPG is between about 90 and 100 mg/dL, the patient's FI is between about 9.5 to about 13 uU/mL, and the predetermined diet is Diet 4;
(xii) the patient's FPG is between about 100 and 115 mg/dL, the patient's FI is between about 9.5 to about 13 uU/mL, and the predetermined diet is Diet 5 or Diet 6;
(xiii) the patient's FPG is between about 115 and 125 mg/dL, the patient's FI is between about 9.5 to about 13 uU/mL, and the predetermined diet is Diet 7 or Diet 8; or
(xiv) the patient's FPG is greater than about 125 mg/dL, the patient's FI is between about 9.5 to about 13 uU/mL, and the predetermined diet is Diet 9 or Diet 10;
wherein diets 1, 2 and 4-10 are defined in the table below:
Diet 1
Carbohydrate: 52-56%
Protein: 19-23%
Fat: 23-27%
Fiber: >30 g/10 MJ
Added sugar: <15E%
Diet 2
Carbohydrate: 28-32%
Protein: 23-27%
Fat: 43-47%
Fiber: >20 g/10 MJ
Added sugar: <5E%
Diet 4
Carbohydrate: 38-42%
Protein: 23-27%
Fat: 33-37%
Fiber: >25 g/10 MJ
Added sugar: <10E%
Diet 5
Carbohydrate: 42-46%
Protein: 19-23%
Fat: 33-37%
Fiber: >30 g/10 MJ
Added sugar: <15E%
Diet 6
Carbohydrate: 35-39%
Protein: 23-27%
Fat: 36-40%
Fiber: >25 g/10 MJ
Added sugar: <10E%
Diet 7
Carbohydrate: 37-41%
Protein: 19-23%
Fat: 38-42%
Fiber: >30 g/10 MJ
Added sugar: <10E%
Diet 8
Carbohydrate: 31-35%
Protein: 23-27%
Fat: 40-44%
Fiber: >20 g/10 MJ
Added sugar: <5E%
Diet 9
Carbohydrate: 32-36%
Protein: 19-23%
Fat: 43-47%
Fiber: >25 g/10 MJ
Added sugar: <5E%
Diet 10
Carbohydrate: 28-32%
Protein: 23-27%
Fat: 43-47%
Fiber: >20 g/10 MJ
Added sugar: <5E%

### Claim 2 (depends on 1)

The method of claim 1, wherein the weight loss is primarily fat loss.

### Claim 3 (depends on 1)

The method of claim 1, further comprising the step of changing the predetermined diet based on changes in the patient's FPG and/or FI over time.