Effect of a Fermented Whey and Fiber Supplement on Digestive Comfort of Recreational Athletes With and Without GI Complaints
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Part I: Hydrogen in breath
研究概览
简要总结
A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections.
Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period).
Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).
详细描述
A substantial number of athletes suffer from gastro-intestinal (GI) problems, which may impair performance and/or subsequent recovery. Regardless of the prevalence of GI complaints, gut barrier integrity is impaired with high-intensity training. Emerging studies show a positive correlation between the gut microbiome and GI problems and general health and wellbeing.
This project will perform two well-controlled studies:
Part I will be looking into the impact of a 3-week supplementation of fermented dairy protein with prebiotic fiber supplement vs. 3-week supplementation of a control supplement on carbohydrate malabsorption (by means of a lactose tolerance test), Bifidobacterium, GI complaints, general well-being and overall gut microbiota in people screened for not reporting substantial GI complaints while being lactose non-persistent (LNP) and/or being responsive to a lactose tolerance test.
Part II investigates the impact of a 3-week supplementation of a fermented dairy protein with prebiotic fiber supplement vs. a control supplement on GI complaints, Bifidobacterium, general well-being, overall gut microbiota, immune markers, gut redox status, and short chain fatty acids in feces in people screened for reporting substantial GI complaints.
Both study parts include multiple standardized exercise tests before and after each supplementation period (Part I: 4 exercise testing days, Part II: 2 exercise testing days). The participants will come in fasted (after not eating starting 10 pm the night before) and they will perform a 60-minute hiking protocol in a warm environment. After the first-time participants will copy their personal exercise protocol during the following session(s). The exercise exists of hiking on a treadmill in a warm environment (30-35°C), while reaching an exercise intensity of 70% of the subject's VO2 max. Which is an intensity in which the subject has an elevated breathing frequency but is still able to talk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aside from having participants fitting the inclusion and
排除标准
- •below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to the Part I (i.e. no self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with all items scored <4 (severe) and a total GSRS score ≤25), or Part II (i.e. Severe self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with at least one item scored ≥4 (severe) and a total GSRS score ≥30). If they don't fit these criteria (i.e., having a GSRS score ranging from 26-29) they will be excluded from participation.
- •Inclusion Criteria:
- •Healthy subjects living in the Phoenix area in AZ, USA during the study
- •Women/Men aged between 18-50 years (50-50%)
- •Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
- •BMI value between ≥18.5 and ≤ 30 kg/m2
- •No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
- •Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.
- •Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.
- •Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).
- •Written informed consent
- •For part I: Self-perceived lactose intolerance, and/or omission of dairy products, and/or identifying as Hispanic/Latino or Asian
- •For part I: Determined to be lactase non-persistent (LNP) CC genotype by qPCR, and/or positive lactose intolerance test (>20ppm increase from baseline when 25g of lactose administered)
- •Exclusion Criteria:
- •Users of (sport) supplements containing probiotics and/or prebiotics and those unwilling to temporarily stop use of these supplements at least 3 weeks prior to start of the intervention
- •Women who plan to start or stop the use of contraceptives before or during study period
- •Women that have additional or worse GI symptoms during their period that can be classified as severe
- •Clinical lactose intolerance
- •Clinical or self-perceived milk protein allergy
- •Diagnosed GI tract disorders or diseases
- •Musculoskeletal disorders
- •Diagnosed metabolic disorders (such as diabetes)
- •Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- •Chronic use of gastric acid suppressing medication or anti-coagulants
- •Chronic use of anti-inflammatory medication
- •Use of antibiotics the past 0-6 months
- •Blood donation in the past 2 months
- •(Intending to become) Pregnant/lactating women
- •Significant changes in body weight during the past 4 weeks (i.e., due to reduction of body weight through limiting caloric intake, illness,)
- •Athletes should not aim to lose bodyweight by reducing energy intake during the study
- •For Part I: A hydrogen breath peak of less than 20 ppm over baseline during a lactose tolerance test
研究组 & 干预措施
Fermented dairy protein with prebiotic fiber
During 3-week period participants consume a fermented dairy protein with prebiotic fiber.
During Part I participants are randomly assigned to start with the experimental arm or the control arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial).
During Part II participants are randomly assigned to the experimental arm only (double blind, randomized parallel trial).
干预措施: Fermented dairy protein with prebiotic fiber supplement (Dietary Supplement)
Control protein supplement
During 3-week period participants consume a control supplement.
During Part I participants are randomly assigned to start with the control arm or the experimental arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial).
During Part II participants are randomly assigned to the control arm only (double blind, randomized parallel trial).
干预措施: Control placebo (Dietary Supplement)
结局指标
主要结局
Part I: Hydrogen in breath
时间窗: For 240 minutes post exercise after consuming a bolus of lactose.
Hydrogen in breath as indicator of lactose malabsorption.
Part II: Gastrointestinal Symptoms Rating Scores
时间窗: For 240 minutes post exercise after consuming a bolus of lactose.
Gastrointestinal Symptoms Rating Scores (GSRS) as indicator of self-reported digestive comfort. The GSRS is a 15-item self-administered questionnaire divided into five clusters of symptoms: reflux, abdominal pain, indigestion, diarrhea, and constipation. These symptoms are graded on a 7-point Likert scale, where 1 signifies no discomfort at all and 7 represents very severe discomfort. The total score will be calculated, as well as the percentage of subjects reporting symptoms (≥2), or moderate to severe symptoms (≥4). A minimal score of indicates no GI symptoms, whereas a score up to 105 suggests extreme GI symptoms.
次要结局
- Part I and Part II: Fecal Bifidobacterium(Stool sample collected at least one day before the test day including the exercise test)
研究者
Floris Wardenaar
Assistant Professor in Nutrition
Arizona State University