Clinical trial NCT03021694: Testing of Micellar Casein, Blended Micellar Casein and Native Whey
Official title: Testing of Micellar Casein, Blended Micellar Casein and Native Whey, Versus Native Whey to Determine Post-ingestion Aminoacidemia, Glycemia, and Insulinemia in Young Adult Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The importance of protein in nutrition is momentous to ones health. Dietary proteins are essentially nutritional because they contain amino acids, which the body uses to build its own proteins, as well as other molecules that are essential for life. Protein when consumed, travels through your digestive system and is absorbed. They then enter the blood for transport to bodily tissues, and therefore, can be detected by blood sampling. There are differing amounts of each amino acid found in different types of protein supplements. Certain amino acids (the essential amino acids) are helping in stimulating muscle growth and helping to maintain muscle mass and function. It is important to understand how quickly these amino acids can be detected in your blood as well as how they affect blood glucose (blood sugar) and insulin activity. Understanding the effects of protein type on changes in levels of blood amino acids, glucose and insulin will provide helpful insight for the suggestion of supplement use.

Detailed description: The importance of protein in nutrition is momentous to ones health. Dietary proteins are essentially nutritional because of their constituent amino acids, which the body uses to synthesize its own proteins, as well as nitrogen-containing molecules that are essential for life. The Recommended Dietary Allowance (RDA) for daily protein intake in healthy adults is 0.8 g/kgBW/day. Younger individuals who participate in recreational or competitive activities, however, often attempt to go beyond the RDA by using protein supplements to help increase performance. For example, it was demonstrated that protein supplementation in conjunction with an eight-week resistance-training program elicited greater improvements in muscle hypertrophy and strength when compared to carbohydrate supplementation in untrained men. There were 3.2 to 17.5% increases in muscle cross-sectional area of the quadriceps femoris musculature and 14.5 to 30.3% strength gains in the leg extensors. Furthermore, several expert groups have recently advocated that certain individuals, such as older persons, should increase their daily intake to 1.0 to 1.5 g/kgBW/day to support the preservation of muscle and function. Other conditions also place greater than normal demands on amino acids, such as hypercatabolic stressed states, like that experienced by burn patients who's muscle protein breakdown rate increases by impairment to inward transmembrane transport of circulating blood amino acids. It was also found that an experimental enriched protein "medical food" comprised of 27% of calories as total protein resulted in postprandial increases in MPS rates for 5 hours by ∼33% (0.073 ± 0.023%∙h-1 to 0.097 ± 0.033%∙h-1) in advanced cancer patients. Thus, continually reassessing new and innovative nutrient therapies is necessary for extending the findings of existing studies after technological advances, and for providing nutritional support-to-support health.

It is well known that dietary protein is a powerful transient stimulator of the muscle protein synthetic rate (MPS) whereby changes in MPS in response to feeding may be regulated by specific downstream target proteins of mammalian target of rapamycin signaling, such as S6K1, rpS6, and eIF2B. A meal deficient in protein, however, does not increase the rate of MPS because a rise in the bioavailability of amino acids does not occur. In addition, the source of dietary proteins has been shown to impact postprandial blood levels of amino acids. The concept that certain types of proteins are "fast acting" or "slow acting" has been shown to affect the postprandial profile of amino acids appearing in the systemic circulation. Native whey and micellar casein are both dairy proteins that contain a similar amount of essential (EAA), but blood EAA levels increase faster and to a higher level after the consumption of whey protein. Differences in gastric emptying, digestion and absorption kinetics between micellar casein and native whey are suggested to be the underlying factors. Nonetheless, micellar casein protein has been shown to protract MPS in humans. Despite the significant amount of information gained with respect to both of these protein sources, the effects of combinatorial formulations on the postprandial profile of amino acids appearing in the blood is less well known. The purpose of the present study is to test a novel blend of micellar casein combined with native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men.

Eligibility criteria: Inclusion Criteria:

* 10 participants will be included in this study.
* Each participant will consume only one of the supplements in a double-blinded fashion during three separate visits and there will be approximately 1 week between each visit.
* In order to participate in this study, each participant must be male, between the ages of 18 and 30 years (inclusive) and cannot be a smoker or user of tobacco products.

Exclusion Criteria:

* The exclusion requirements for this study include the following conditions:

  * Take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded. However, a washout period of 4 weeks will be suitable for participation.
  * A history of neuromuscular problems or muscle and/or bone wasting diseases
  * Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
  * Use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)

Primary outcomes:
measure: Postprandial blood amino acid concentrations
timeFrame: 360 minutes
measure: Postprandial blood insulin concentrations
timeFrame: 360 minutes
measure: Postprandial blood glucose concentrations
timeFrame: 360 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Exercise Metabolism Research Laboratory, McMaster Univeristy
state: Ontario
Study officials:
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