None listed
Conditions
Brief summary
This project builds on previous studies that suggest consumption of hydrolysed collagen preparations may alleviate symptoms of osteoarthritis, the most common type of arthritis, usually affecting the knee, and with limited options for treatment. Inflammation and concomitant destruction of collagen in the connective tissue extracellular matrix are common mechanisms in osteoarthritis. Furthermore, most global collagen supplements are marketed as anti-ageing nutricosmetics to enhance skin appearance. Evidence from placebo-controlled studies is inconsistent, particularly in relation to the effects on skin, and most studies select a non-protein or noncaloric substance as a placebo. The proposed project will investigate the effects of a novel hydrolysed collagen preparation to initiate collagen synthesis and examine the effects of collagen hydrolysate on joint comfort and skin appearance. The study will compare the collagen hydrolysate preparation with milk protein and the typical placebo used in other studies. We will test the hypothesis that collagen hydrolysate positively affects the balance between collagen synthesis and degradation and improves pain scores and inflammation. The study will investigate the effects of consuming 15g of protein from collagen hydrolysate or milk powder daily for 17 weeks (4 months) on women aged 50 or over with signs and symptoms of early osteoarthritis.
Interventions
Participants will consume 15g of protein as collagen hydrolysate or milk protein or placebo per day for a total of 17 weeks (4 months). The supplements will be provided as powder in plain vacuum-sealed sachets; the powder will be added to drinks or cereal (normal components of the participant's daily diet). Once enrolled in the trial, participants will be randomly allocated to either one of the two active intervention groups or to the placebo comparator group.
All participants will also be pro
Participants will consume 15g of protein as collagen hydrolysate or milk protein or placebo per day for a total of 17 weeks (4 months). The supplements will be provided as powder in plain vacuum-sealed sachets; the powder will be added to drinks or cereal (normal components of the participant's daily diet). Once enrolled in the trial, participants will be randomly allocated to either one of the two active intervention groups or to the placebo comparator group. All participants will also be provided with a low-dose multivitamin preparation (daily tablet to be taken concurrently with the supplement) to ensure micronutrients essential for collagen synthesis are not rate-limiting. The multivitamin will contain 100mg ascorbic acid, 5mg iron, 10mg zinc, 2mg manganese and 600[micro]g copper and will be supplied from Blackmores Ltd, Australia. Participants will be monitored for compliance with the protocol by email or phone communication and a compliance diary (to assess study compliance, nutrient intake and medication use; they will return unused sachets of supplement at the end of the trial.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Healthy women aged 50 and over. BMI 20-40 Presence of self-reported knee pain ("Yes" response to "During the past 6 months, have you had any knee pain for more than half the days in the month?") and KOOS pain score indicating mild osteoarthritis. Willing to stop taking dietary supplements from 4 weeks before and during trial.
Exclusion criteria
Vegetarian (unless willing to consume a collagen/gelatine supplement) Lactose intolerance Taking medication (other than over the counter pain relief for osteoarthritis or prescribed medication known not to affect outcomes) Known heart/renal/hepatic disease, rheumatoid arthritis or other autoimmune inflammatory disorders History of trauma (or surgery) affecting knees within 6 months Heavy smoker Heavy alcohol consumer (more than 2 units of alcohol per day) High weekly intake of meat Conditions with altered ability to digest and absorb dietary protein (e.g. bariatric surgery) Already consuming (or consumed within 6 months) oral nutrition supplements containing any amount of chondroitin, glucosamine, or collagen. Starting hormone replacement therapy (HRT) within 6 months.
Outcome results
None listed