Effects of a milk-based bioactive micronutrient beverage on pain symptoms and activity of adults with osteoarthritis: a double-blind, placebo-controlled clinical evaluation.
OBJECTIVE
A 6 wk, double-blind, placebo-controlled study investigated the effects of a nutritional supplement beverage containing milk-based micronutrients and fortified with vitamins and minerals on pain symptoms and activity in adults with osteoarthritis.


METHODS
Thirty-one subjects with osteoarthritis of both knees were randomized into two groups and given 12 oz daily of the micronutrient-containing beverage or a placebo for 6 wk. Subjects were instructed not to change their normal activities and diets. Body weights, vital signs, blood chemistries, and adverse events were monitored to assess safety. The principal outcome measurement for efficacy was the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) derived from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire administered weekly.


RESULTS
Safety indicators remained unchanged in the test and placebo groups. All KOOS scores improved significantly (P < 0.03) over time in the micronutrient group, whereas scores only for sport function and knee-related quality of life improved in the placebo group. The overall treatment effect (based on changes in the WOMAC composite score) was significant (P = 0.016). The effect size was moderate at 0.555.


CONCLUSIONS
Thus, daily consumption of the nutritional beverage containing milk-based micronutrients, vitamins, and minerals was beneficial in alleviating symptoms and dysfunction in subjects with osteoarthritis.
Colker
Carlon M
CM
Peak Wellness Foundation, Inc., Greenwich, Connecticut 06830, USA.
Swain
Melissa
M
Lynch
Leila
L
Gingerich
Daniel A
DA
D000203:Activities of Daily Living; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D012449:Safety; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014815:Vitamins / Q000008:administration & dosage*
D008903:Minerals; D014815:Vitamins