An Assessment of the Effects of a Nutritional Supplement Program on Healthy Aging

In patients with osteoarthritis of the knee does Ambrotose powder, Ambrotose AO, Phytomatrix and Plus 1, increase the quality of life and fatigue level?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000613404

Acronym

None

Enrollment

Registered

2007-11-28

Start date

2008-02-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to determine the efficacy and safety of a Mannatech product in improving quality of life and reducing fatigue in participants with diagnosed osteoarthritis of the knee. Participants will take 4 Mannatech preperations twice a day with food for 8 weeks, they will attend a clinic at baseline, week 4 and week 8. At these times they will complete the study questionnaires. Blood wil be taken at baseline and week 8 to determine safety parameters.

Interventions

Ambrotose powder 1 teaspoon twice a day with food for 8 weeks Ambrotose AO, 2 capsules twice a day with food for 8 weeks Phytomatrix 1 capsule twice a day with food for 8 weeks Plus 1 capsule twice a day with food for 8 weeks

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Females and males, aged between 18 and 85 years X-ray and clinical evidence of osteoarthritis of the knees In good general health Adequate venous access Female participants of childbearing age who agree to continue using birth control measures for the duration of the study

Exclusion criteria

A history of trauma associated with the affected joint Rheumatoid or other inflammatory joint conditions Gout Individuals with thyroid disorder Individuals with diabetes Individuals taking antidepressants Individuals taking Warfarin of other anti-coagulant medication Individuals who are lactose intolerant Participants with a VAS score above 7 at baseline. Participants who have just commenced on a treatment regimen for arthritis Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study Liver function tests greater than 3 times the upper limit of normal at baseline History of alcohol or substance abuse History of allergy to iodine or shell fish Female participants who are lactating, pregnant or planning to become pregnant Participants who have participated in another clinical trial in the last 30 days Participants unwilling to comply with the study protocol Any other condition, which in the opinion of the investigators could compromise the study

Outcome results