Trial Outcomes & Findings for Nutramax Joint Health Formulation Biochemical Response Study (NCT NCT02614274)

Results Overview

Blood will be assessed using a proprietary panel of biomarkers of inflammation. Blood and urine were collected, processed, and analyzed using a proprietary panel of biomarkers using the Luminex system as previously described (Garner, et al; Roller, et al). In addition, serum hsCRP was analyzed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

42 days

Results posted on

2018-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Nutraceutical Joint Health Formulation A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nutramax Joint Health Formulation Biochemical Response Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nutraceutical Joint Health Formulation n=9 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

Blood will be assessed using a proprietary panel of biomarkers of inflammation. Blood and urine were collected, processed, and analyzed using a proprietary panel of biomarkers using the Luminex system as previously described (Garner, et al; Roller, et al). In addition, serum hsCRP was analyzed.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Serum Biomarkers PGE2	130 pg/ml Standard Deviation 17
Serum Biomarkers MMP1	114 pg/ml Standard Deviation 48
Serum Biomarkers GRO	109 pg/ml Standard Deviation 63
Serum Biomarkers IL8	63 pg/ml Standard Deviation 3
Serum Biomarkers hsCRP	14 pg/ml Standard Deviation 1

PRIMARY outcome

Timeframe: 42 days

Urine will be assessed using a proprietary panel of biomarkers of inflammation.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Urine Biomarkers PGE2	7.9 pg/ml Standard Deviation 5.8
Urine Biomarkers MMP2	17.2 pg/ml Standard Deviation 10
Urine Biomarkers MMP3	3.2 pg/ml Standard Deviation 3
Urine Biomarkers GRO	2.9 pg/ml Standard Deviation 2.9
Urine Biomarkers IL8	1 pg/ml Standard Deviation 1

SECONDARY outcome

Timeframe: 42 days

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Mean+-SD among of improvement is reported.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Physical Function	70 units on a scale Standard Deviation 30.8
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Role limitations due to physical health	50 units on a scale Standard Deviation 54.8
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Role limitations due to emotional problems	80 units on a scale Standard Deviation 44.7
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Energy/fatigue	70 units on a scale Standard Deviation 11
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Emotional well being	77.6 units on a scale Standard Deviation 11.1
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Social functioning	92.5 units on a scale Standard Deviation 12.4
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement Pain	71 units on a scale Standard Deviation 15.9
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement General health	81 units on a scale Standard Deviation 24.9

SECONDARY outcome

Timeframe: 42 days

Knee injury and Osteoarthritis Outcome Score (KOOS). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) Symptoms	44.3 units on a scale Standard Deviation 23.1
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) Pain	50.6 units on a scale Standard Deviation 19.4
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) Sports	37 units on a scale Standard Deviation 23.9
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) Quality of Life	30 units on a scale Standard Deviation 28.4
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) Activities of Daily Living	60 units on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: 42 days

The Western Ontario and McMaster Universities Arthritis Index (WOMAC). A lower score indicates less severe symptoms, a higher score indicates more severe symptoms. The range of scores as is follows: 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Function.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Patient Reported Survey to Assess: Pain, Stiffness, and Physical Function in Patients With Hip and/or Knee Osteoarthritis (OA) Via WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain	10.8 units on a scale Standard Deviation 5.6
Patient Reported Survey to Assess: Pain, Stiffness, and Physical Function in Patients With Hip and/or Knee Osteoarthritis (OA) Via WOMAC (Western Ontario and McMaster Universities Arthritis Index) Stiffness	3.6 units on a scale Standard Deviation 2.2
Patient Reported Survey to Assess: Pain, Stiffness, and Physical Function in Patients With Hip and/or Knee Osteoarthritis (OA) Via WOMAC (Western Ontario and McMaster Universities Arthritis Index) Function	26.4 units on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: 42 days

International Knee Documentation Committee (IKDC). Each subscale is scored from 0-100, with 100 being no limitation with activities of daily living or sports activities and the absence of symptoms.

Outcome measures

Outcome measures
Measure	Nutraceutical Joint Health Formulation n=5 Participants A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam Symptoms	56.8 units on a scale Standard Deviation 29.1
Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam Sports	57 units on a scale Standard Deviation 26.4
Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam Function	52 units on a scale Standard Deviation 34.4

Adverse Events

Nutraceutical Joint Health Formulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nutraceutical Joint Health Formulation n=9 participants at risk A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
Nervous system disorders headache	11.1% 1/9 • Number of events 1

Additional Information

James L. Cook, Director of Research

University of Missouri

Phone: 573-884-4689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place