Bovine Colostrum Supplementation in Athletes
Condition: Innate Immunity
Study type: Interventional

Summary: 
      32 recreational athletes who will attend to the Grand Marathon in the nort west of Mexico,
      event that will be held on December 2, 2018 or 21k Trail to be held in April 2019 will be
      invited to the study. Participants will be informed about the study procedures through a
      consent informed. Participants will be randomly divided into two groups, 16 in the
      intervention group and 16 in the comparison group. The participants will be recreational
      athletes between 18 and 60 years old. They must have athletic experience of at least 3 years.
      The participants considered will be those who perform vigorous physical activity per week
      according to the criteria of the short version IPAQ instrument. Smoking subjects with food
      intolerances and allergies, cardiovascular history will be excluded. Patients who have had a
      respiratory infection symptom in the last two weeks will not be able to participate in the
      study. Participants who are consuming some type of food supplement will be excluded.

      Two 18 ml of blood samples will be taken from the vein of the forearm by venipuncture of each
      participant, using K2EDTA tubes after and before supplementation period. Blood samples were
      taken before a corporal, aerobic and nutritional evaluations.

      CB supplementation will begin 4 weeks prior to competition events. One group will consume 20
      g of bovine colostrum daily in solution with water. The second group will consume a placebo
      product with a nutritional composition similar to the group with the treatment of bovine
      colostrum. Both groups should take the supplement before breakfast with empty stomach.
    

Detailed description: 
      It is widely accepted that exercise provide important health benefits. However, vigorous or
      extenuate exercise can affect the correct function of the immune system. Athletes who perform
      extreme physical routines to improve their athletic performance can develop opportunistic
      infections. After 3 to 72 h of physical activity there is a phase called "open window for
      infection", which predispose to upper track respiratory infection (UTRI). URTI is the main
      cause of medical consultation in athletes with vigorous exercise practices.

      Neutrophils are one of the most abundant leucocytes in blood; their phagocytic activity is
      essential to control bacterial infections. Recently, the interest in knowing the
      participation of these cells in the sport field is growing. Neutrophilia refers to a high
      concentration of neutrophils in blood, and this is a common condition after exercise. The
      controversial part is that vigorous exercise could limit some important functions, such as
      oxidative burst, degranulation and phagocytosis until 6 h after exercise. However, there are
      contradictory results in this topic.

      To alleviate those immunological alterations in athletes, a nutritional intervention should
      be included. Bovine colostrum has been evaluated as a supplement due to its potential
      immunomodulatory properties. It improves immunological parameters in individuals who achieve
      prolonged exercise sessions, allowing URTI reduction. Bovine colostrum is a yellow aqueous
      compound secreted by cow mammary glands the first 72 h after partum. Bovine colostrum
      contains anti-microbial peptides, enzymes, immunoglobulins, cytokines, microRNA and growth
      factors, which are able to modulate the immune system, at local (intestinal) and systemic
      level. Due to these characteristics, bovine colostrum has been used to improve the immune
      response under different physiological conditions.

      A study showed that bovine colostrum supplementation induces a CD89 expression pre-exercise,
      after 5 weeks supplementation with 10 g of bovine colostrum. This result is important, since
      CD89 is a membrane receptor in neutrophils that recognize antibody/antigen complexes to prime
      phagocytosis and degranulation. In other study, 3 weeks of bovine colostrum supplementation
      improved neutrophil degranulation 1 h post-exercise in athletes, after 2 h of physical
      exercise. Authors evaluated neutrophil oxidative burst post-exercise after bovine colostrum
      supplementation, but no effects were observed. However, these authors found better oxidative
      burst after 4 weeks bovine colostrum supplementation. At this time, the effect of bovine
      colostrum in phagocytosis activity is unknown.

      Concerning the effects of bovine colostrum supplementation in the URTI incidence, the results
      are contradictory. Although, others found no benefit in the incidence of URTI after a bovine
      colostrum supplementation, other studies showed promising results. A retrospective analysis
      conducted in 2003 showed a reduction of athletes with URTI in the bovine colostrum
      supplementation group. Likewise, another study reported less episodes and duration of
      infections in physically active subjects. Other studies described a tendency to decrease the
      incidence of URTI in swimmers and cyclists.

      Study Design

      A total of 28 athletes attending the "Hermosillo Grand Marathon" (December 2, 2018) and/or
      the "Hermosillo Half Marathon" (March 2019) will be part of this study. In this randomized
      clinical trial, study subjects will be randomly divided in two groups, 14 in the intervention
      group (bovine colostrum supplementation) and 14 in the comparison group (placebo
      supplementation). The participants will be recreational athletes between 18 and 60 years old.
      They must have athletic experience of at least 3 years and have to perform a vigorous
      physical activity per week according to the criteria of the short version IPAQ instrument.
      Smoking subjects, with food intolerances, allergies or cardiovascular history will not be
      included. Athletes with respiratory infection symptoms two weeks before beginning the
      supplementation won't be part of this protocol. Participants who are consuming some other
      type of food supplement will not be included. This protocol is currently under evaluation of
      the Ethics Committee of our institution. Participants will be informed about the study
      procedures and will sign an informed consent.

      Bovine colostrum supplementation will begin 4 weeks prior to the competition event. The
      intervention group will consume 20 g of bovine colostrum, divided into two doses of 10 g/day.
      The first dose will be before breakfast and the second before lunch. The comparison group
      will consume a placebo product.

      Two blood samples (24 ml of each one) will be taken from the vein of the forearm of each
      participant, using tubes with EDTA. The first sample will be taken before the competitive
      event after 10 min of a sitting rest. The second sample will be obtained immediately at the
      end of the test with 3 minutes of sitting rest.
    

Intervention name(s): Colostrum bovine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Colostrum bovine supplements, 25 kcal per portion, containing 0.25 g fats, 2.0 g CHO and 3 g protein. Lactose reduced.; Dairy comercial product. 25 kcal per portion, 1.3 g fats, 1.95 CHO and 1.3 protein. Lactose based.
Other intervention name(s): sovereign laboratories colostrum ld powder; Milk powder
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention