跳至主要内容
临床试验/NCT05664269
NCT05664269招募中不适用

The Evaluation of Canola Protein and Whey Protein to Support Muscle Conditioning in Vivo in Young Females

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
Postprandial muscle protein fractional synthesis rate

研究概览

简要总结

Muscle tissue consists of proteins. These proteins are built up of small building blocks: amino acids. By consuming enough protein in our diet, we make sure that the body is provided with enough amino acids to facilitate muscle protein building. Also after exercise is protein intake important as it contributes to the recovery process. Providing the growing world population with sufficient animal-derived protein is a challenge. Plant proteins can be produced on a more sustainable commercial scale than conventional animal-derived proteins and therefore, can contribute to feeding our future population. Canola protein is a protein that is derived from rapeseed. The composition of canola seems to be comparable to that of other high-quality animal-based protein sources. But there is no data yet on the effect of canola protein ingestion on muscle growth. Additionally, most research on the effect of protein intake and muscle growth/recovery has been performed in males and we need more insight into the effect in females. The goal of this study is to investigate whether the ingestion of canola protein can stimulate muscle growth just as good as whey protein after a strength exercise session in females.

Primary objective: To assess the impact of 20g canola or 20g whey protein vs placebo ingestion on acute 5-hour postprandial muscle protein synthesis rates during recovery from lower-body resistance-type exercise in vivo in young females.

Secondary objective: To assess the impact of 20g canola protein vs 20g whey protein ingestion on acute 5-hour postprandial muscle protein synthesis rates during recovery from lower-body resistance-type exercise in vivo in young females.

Tertiary objectives: Compare signaling pathways and. postprandial 5-hour plasma glucose, insulin, and amino acid concentrations, (including area under the curve, peak concentrations, and time to peak) following canola protein, whey protein, and placebo ingestion during recovery from lower-body resistance-type exercise in young females.

Hypothesis: it is hypothesized that acute 5-hour postprandial muscle protein synthesis rates will be not different following 20g canola protein and 20g whey protein ingestion and higher compared to placebo during lower-body post-exercise recovery in healthy young females.

详细描述

Screening and pre-testing To assess whether volunteers are eligible to participate in this study, we will invite them to the University for a screening. At the start of the screening session, the entire experimental trial will be explained and any potential questions will be answered. Thereafter, the volunteers are asked to read, fill out, and sign the informed consent form. After signing the informed consent form, the participant's eligibility will be assessed based on the in- and exclusion criteria. To further assess their eligibility, participants will be asked to fill out a medical questionnaire to assess their general health, use of medication, habitual food intake, and physical activity (Appendix F1.1). Next, blood pressure will be assessed. Body mass (with accuracy of 0.1 kg) and height (with accuracy of 0.01 m) will be determined, and body composition will be assessed via a Dual Energy X-ray Absorptiometry (DEXA) scan. A DEXA scan is a simple, non-invasive procedure. At the beginning of the procedure, subjects will be asked to lie down on a scanning table wearing underwear and they need to remain motionless during the measurements. As the scanner moves, a dual energy beam passes through the targeted skeletal muscle section and is measured by a detector. This procedure is repeated until the whole body is scanned and takes approximately 3 minutes.

The screening sessions will take place in the morning and participants are instructed to not have any breakfast in the morning in order to avoid perturbations in the DEXA scan.

In the event of an unexpected medical finding during the screening, subjects will always be notified. If a subject does not want to receive this notification, she cannot participate in the study.

Next, subjects will be familiarized and tested for bilateral strength on the exercise machines. First, participants will warm up on a cycle ergometer for 5 minutes at 100W. Subjects will be instructed on proper weight-lifting technique on each exercise machine (leg-press and leg-extension) and complete a standardized testing protocol to determine a measurement of maximal strength (1RM) for each exercise machine. In short, subjects will be seated on a leg press and leg extension machine and start with a warm-up of 2 sets of 10 repetitions with self-chosen weights. Then the load will be increased above the warming-up weight. The load will be increased after each successful lift, until failure, to determine maximal strength. A repetition is classified as "valid" if the participant is able to complete the entire lift in a controlled manner, without assistance.

When the screening is successfully performed, the test day will be scheduled. In order to prevent major impact from the menstrual cycle on the measurements of protein metabolism, the test day will be scheduled to take place in the first 10 days of the follicular phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Randomization of interventional drinks will be performed by an independent researcher who will also prepare the drinks on the morning of the test day. Drinks will be prepared in a non-transparent shaker and matched for taste.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female sex
  • Aged between 18 and 35 y inclusive
  • BMI between 18.5 and 30 kg/m2

排除标准

  • Intolerant to milk products
  • Mustard allergy
  • Participating in a structured (progressive) exercise program
  • Smoking regularly
  • Diagnosed GI tract disorders or diseases
  • Diagnosed musculoskeletal disorders
  • Diagnosed metabolic disorders (e.g. diabetes)
  • Hypertension (blood pressure above 140/90 mmHg)
  • Donated blood 3 months prior to test day
  • Using third generation oral contraceptives
  • Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
  • Chronic use of gastric acid suppressing medication
  • Chronic use of anti-coagulants
  • Recent (<1 year) participation in amino acid tracer (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine studies

结局指标

主要结局

Postprandial muscle protein fractional synthesis rate

时间窗: 0-5 hours

Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.

次要结局

  • Plasma insulin concentrations(0-5 hours)
  • Plasma glucose concentrations(0-5 hours)
  • 'basal' muscle protein fractional synthesis rate(-3 - 0 hours)
  • Plasma amino acids concentrations(0-5 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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