Granted Patent B2

US 12,746,257 · App. 19/067,509 · Granted Sep 29, 2026

Inventors: Ronald Kramer (Signal Hill, CA); Alexandros Nikolaidis (Nea Kallikratia, GR)

Assignee: ThermoLife International, LLC

A61K33/26A61K9/0056A61K9/20A61K31/375A61K36/21A61P43/00

Abstract

Claims (31)

1 . A method of replenishing a human subject's iron, ferritin, and/or hemoglobin level, the method comprising:

orally administering elemental metal iron to the subject; and

orally administering a source of nitrate anion to the subject.

2 . The method of claim 1 , wherein the source of nitrate anion is a nitrate salt.

3 . The method of claim 2 , wherein the source of nitrate anion is potassium nitrate.

4 . The method of claim 1 , wherein the source of nitrate anion is a botanical source.

5 . The method of claim 4 , wherein the botanical source is an Amaranthus extract or beetroot extract.

6 . The method of claim 1 , wherein the elemental metal iron has a mesh size of 325.

7 . The method of claim 1 , further comprising orally administering an acid to the subject.

8 . The method of claim 7 , wherein the subject is orally administered a composition comprising the elemental metal iron; source of nitrate anion; and the acid.

9 . The method of claim 1 wherein the subject is diagnosed with anemia, low blood iron level, low ferritin level, and/or low hemoglobin levels.

10 . The method of claim 9 , wherein the subject exhibits at least one symptom selected from the group consisting of: extreme fatigue, weakness, pale skin, chest pain, fast heartbeat, shortness of breath, headache, dizziness, lightheadedness, cold extremities, tongue inflammation, tongue soreness, brittle nails, pica, and poor appetite.

11 . The method of claim 9 , wherein the subject's hemoglobin level is reduced from donating blood.

12 . The method of claim 1 , wherein the subject has donated blood.

13 . The method of claim 12 , wherein the subject's hemoglobin level is lower than that before donating blood.

14 . The method of claim 1 , where the subject exhibits reduced gastrointestinal side effect compared to oral administration of iron salts or elemental metal iron alone.

15 . The method of claim 14 , wherein the gastrointestinal side effect is at least one side effect selected from the group consisting of: diarrhea, stomach pain, heartburn, nausea, vomiting, black stools, and constipation.

16 . The method of claim 1 , wherein the subject is administered 10 mg elemental metal iron and 87.5 mg nitrate anion, the method further comprising orally administering 100 mg ascorbic acid to the subject.

17 . The method of claim 1 , wherein the subject is administered 0.004-0.22 mmol elemental metal iron/kg body weight and 0.08-1.2 mmol nitrate anion/kg body weight.

18 . The method of claim 17 , wherein method further comprises orally administering to the subject 0.009-0.12 mmol ascorbic acid/kg body weight.

19 . The method of claim 18 , wherein the subject is administered 0.0032 mmol elemental metal iron/kg body weight, 0.1000 mmol nitrate anion/kg body weight, and 0.0101 mmol ascorbic acid/kg body weight.

20 . A method of increasing oral bioavailability of elemental metal iron in a human subject, the method comprising:

orally administering elemental metal iron to the subject; and

orally administering a source of nitrate anion to the subject, wherein the elemental metal iron and the source of nitrate anion are co-administered.

21 . The method of claim 20 , wherein the nitrate anion is of a botanical source, wherein the botanical source is an Amaranthus extract or beetroot extract.

22 . The method of claim 20 , wherein the elemental metal iron has a mesh size of 325.

23 . The method of claim 20 , further comprising orally administering an acid to the subject.

24 . The method of claim 23 , wherein the acid is co-administered with the elemental metal iron and the source of nitrate anion.

25 . The method of claim 24 , wherein the subject is orally administered a composition comprising the elemental metal iron; the source of nitrate anion; and the acid.

26 . The method of claim 1 , where the subject exhibits no side effects from oral administration of the elemental metal iron and the source of nitrate anion.

27 . The method of claim 20 , wherein the source of nitrate anion is a botanical source.

Assignments (1)

Continuity (4)

References Cited (400)