MBP® Clinical Evidence

International Dairy Journal

Aoyagi, Y., et al. Interactive effects of milk basic protein supplements and habitual physical activity on bone health in older women: A 1-year randomized controlled trial. 2010; 20:72430.

Topic:
Does supplementing with milk basic protein (MBP), coupled with exercise, improve bone density and strength in postmenopausal women?

Background:
Osteoporosis, a special concern for postmenopausal women, occurs when the rate of bone resorption outpaces the rate of new bone formation. Milk basic protein has been shown in previous research to slow resorption and promote bone formation. But previous studies have concentrated on young and middle-aged adults and have not taken into account the role of exercise in preserving bone.

Study Type:
Human clinical intervention trial.

Study Design:
Randomized, controlled trial. Subjects took MBP and wore a pedometer/accelerometer to assess their levels of physical activity. Biochemical markers of bone metabolism were measured in the forearm and heel at 6 months and 1 year. At the same time, the data from the meters was averaged.

Subjects:
79 healthy women, aged 65-86 years

Dosage:
40 mg/day for 1 year

Results:

  • The MBP group had significantly lower levels of deoxypyridinoline, a marker of bone resorption, and of cross-linked N-telopeptides of type I collagen (NTx), a marker of bone turnover.
  • Subjects in the MBP group maintained their levels of bone mineral density (BMD) and had a 1.5% increase in bone strength in the heel.
  • Deoxypyridinoline and NTx levels were also significantly associated with levels of physical activity.

Conclusion:
“MBP reduced markers of bone loss, particularly in the lower extremities. Reduced resorption of bone was also associated with moderate-intensity/duration exercise. MBP therapy interacting significantly with habitual physical exercise.”

Osteoporosis International

Uenishi, K., et al. Milk basic protein increases bone mineral density and improves bone metabolism in healthy young women. 2007; 18:38590.

Topic:
How does milk basic protein (MBP) affect bone mineral density (BMD) and bone metabolism in young women?

Background:
The most effective way to prevent osteoporosis late in life may be to ensure healthy bone growth in early adulthood, during the period of peak bone mass. MBP has been shown to reduce bone resorption and promote bone formation in both in vitro and in vivo studies.

Study Type:
Human clinical intervention trial.

Study Design:
Randomized, double-blind, placebo-controlled. Subjects took MBP. Researchers measured their BMD at the spine at base line and 6 months and took blood and urine samples to analyze for markers of bone metabolism at base line, 3 months, and 6 months.

Subjects:
35 healthy young women, mean age 21.3 years

Dosage:
40 mg/day for 6 months

Results:
The women in the treatment group gained significantly more BMD in the spine (1.57% v. 0.13%). Their levels of cross-linked N-telopeptides of type 1 collagen (NTx), a marker of bone turnover, were significantly decreased and their levels of osteocalcin, a bone-building protein, were significantly increased.

Conclusion:
“These results suggest that MBP supplementation was effective in increasing BMD in young women and that this increase in BMD may be primarily mediated through the promotion of bone formation and inhibition of bone resorption by MBP supplementation.”

Aoe, S., et al. A controlled trial of the effect of milk basic protein (MBP) supplementation on bone metabolism in healthy menopausal women. 2005; 16:21238.

Topic:
Can milk basic protein (MBP) help prevent bone loss in postmenopausal women?

Background:
People with osteoporosis have low bone mineral density (BMD) and are vulnerable to bone fractures. Postmenopausal women are at special risk.

Study Type:
Human clinical intervention trial.

Study Design:
Randomized, double-blind, placebo-controlled. Subjects took MBP or a placebo and their BMD was measured at the spine at base line and at 6 months, while urine and blood samples were analyzed for markers of bone metabolism at base line, 3 months, and 6 months.

Subjects:
32 healthy, postmenopausal women, mean age 50.5 years

Dosage:
40 mg/day for 6 months

Results:

  • Serum cortisol increased by 45% in the placebo group, whereas in the ETAS™50 group it increased by only 10%.
  • This represents a suppression of the rise in cortisol caused by stress of roughly 80%. Salivary cortisol increased by only 47% in the ETAS™50 group compared with 75% in the control group.
  • A marker of psychological stress known as chromogranin A decreased 2.5 times more in the ETAS™50 group compared with the control group.

Conclusion:
“These results suggested that MBP supplementation was effective in preventing bone loss in menopausal women and that this improvement in BMD may be primarily mediated through the inhibition of bone resorption while maintaining the balance of bone remodeling by MBP supplementation.”

Bioscience, Biotechnology, and Biochemistry

Yamamura, J., et al. Milk basic protein (MBP) increases radial bone mineral density in healthy adult women. 2002; 66(3):702–4.

Topic:
Can milk basic protein (MBP) improve bone mineral density (BMD) in women?

Background:
MBP is thought to improve BMD by promoting bone formation and reducing bone resorption, specifically by inhibiting osteoclasts, bone cells responsible for breaking down bone. The radius was chosen as the test site because arm bones are less affected by body weight.

Study Type:
Human clinical intervention trial.

Study Design:
Randomized, double-blind, placebo-controlled. Subjects took MBP or a placebo. BMD at the radius was measured at base line and at 6 months.

Subjects:
33 healthy adult women, mean age 28.8 years

Dosage:
40 mg/day for 6 months

Results:
BMD increased significantly at two sites on the radius.

Conclusion:
“MBP supplementation increased BMD in healthy adult women. From this study, it appears that 40 mg per day of MBP supplementation is effective in promoting bone metabolism and an increase in BMD, at least in their radius. MBP can thus be considered a nutritional component capable of increasing peak bone mass and reducing further risk of osteoporosis in premenopausal women.”

Mechanism of Action

Milk basic protein (MBP), a fraction of whey protein found in milk, is biologically active, consisting of approximately 54% lactoferrin and 41% lactoperoxidase, angiogenin, and Cyastin C. These peptides promote bone formation, suppress bone atrophy, and decrease the formation of osteoclast pits which act to break down bone. It increases bone mineralization, stimulates formation of new osteoblasts, the bone cells which are involved in collagen production and bone growth. Lactoferrin increases osteoblast differentiation. Angiogenin inhibits osteoclast-mediated bone resorption by directly acting on osteoclasts reducing formation of the F-actin ring and mRNA levels of tartrate-resistant acid phosphatase and cathepsin K, factors involved in the bone-resorptive activity of osteoclasts