The placebo is olive oil, stripped of polyphenols, 70% oleic acid, and will be administered at two 1 gram capsules per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

POA Dose 1 is a 1 gram capsule containing 500 mg POA and one placebo capsule containing 500 mg olive oil per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

POA Dose 2 is two, 1 gram capsules containing 500 mg POA, totaling 1,000 mg POA per day for twelve weeks.The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

Chronic Inflammation

Overweight

The placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose.

Placebo

Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA

Palmitoleic acid, 500 mg (Dose 1)

Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA

Palmitoleic acid, 1,000 mg (Dose 2)

University of North Carolina Nutrition Research Institute

Effect of Palmitoleic Acid on C-reactive Protein

Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans

Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.

Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate glucose/insulin ratio level.

Fasting blood draws will be used to evaluate HbA1c level.

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

University of North Carolina, Chapel Hill

Organic Technologies

12-week randomized, double blinded study in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects.

Administration of the POA supplements and placebo (olive oil capsules) will be via a simple randomized double-blinded allocation. The study sponsor will provide the Principal Investigator with bags, or boxes, of single serve packets containing two capsules for each daily dose per participant in accordance with the proper dosage for each of the three arms of the study. The study sponsor will hold the code for the subjects and will randomize the capsules. No site personnel will have access to the randomization allocation; only the study sponsor will have the code. The identity of the capsules will be revealed once all analyses are complete.

Adult patients undergoing elective surgery
Having a CPET as part of routine care
Patients with a Hb value of < 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency.
Able to provide written informed consent.

Plasma stored in freezers at University Hospital Southampton

Anemia

Anemia, Iron Deficiency

Anaemic patients undergoing major surgery who would routinely be receiving intravenous iron 'MonoFer' will get this as part of routine care. They will then have a CPET repeated at least 10 days afterwards.

MonoFer

University Hospital Southampton NHS Foundation trust

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Cardiopulmonary Exercise Testing Before and After Intravenous Iron: a Prospective Clinical Study

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at anaerobic threshold before and then after intravenous iron therapy.

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at peak exercise before and then after intravenous iron therapy therapy

Laboratory measured haemoglobin concentration

By using the optimised carbon monoxide rebreathing technique (oCOR) total haemoglobin mass will be measured before intravenous iron therapy and then again after intravenous iron therapy

Hepcidin is iron regulatory hormone produced in the liver that affects iron transport. This will be measured twice.

Ferritin is an acute phase protein but it is also the body major storage protein for iron.

Plasma marker of iron storage and availability.

Hospital length of stay after to include entire perioperative stay. (This is routinely collected already as part of the preoperative optimisation of anaemia before surgery (POAS) service.)

Additional blood tests taken as part of the volume descriptive biomarker panel.

Data will not be shared outside of the study team

University Hospital Southampton NHS Foundation Trust

University College, London

University of Bayreuth

Group B - Used Michigan Occlusal Splint (MOS); Group C - Used Planas Oral Appliance (POA).

poa/inflammation

Effect of Palmitoleic Acid on C-reactive Protein

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Efficiency of Two Occlusal Splints on TMD Treatment of Police Officers

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