Comparing the Gastric Transit of Commercial Milk Containing A1 Beta-casein and A2 Milk Containing Only A2 Beta-casein Using Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Volume of milk in stomach/gastric transit
研究概览
简要总结
Cow's milk contains two types of β-casein: A1 and A2. The μ-opioid peptide BCM-7 is released from A1 but not from A2. BCM-7 is associated with slower gastrointestinal transit and hence increased gastrointestinal transit times. Lactose maldigesters reported an increase in abdominal pain due to consumption of milk containing A1 beta-casein as compared to milk containing only A2 beta-casein. The hypothesis of this study is that the differential abdominal pain is due to the differential gastric transit. This is a double-blinded, randomized, controlled trial conducted to determine if the transit of A1 β-casein milk is modified in the stomach as compared to milk with only A2 β-casein.
详细描述
Recruitment:
Flyers, emails, and advertisements in local and university newspapers will be used for recruitment of study participants.
Phone screening:
Interested individuals will be contacted via phone by study staff to assess eligibility by asking questions listed in the inclusion and exclusion criteria.
Informed consent:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability/desire to provide informed consent
- •Aged 18 to 65 years of age inclusive at screening
- •Milk intolerant and identified as a lactose maldigester while participating in the Milk Protein Study (applicable only for subjects from the previous milk protein study and not applicable for new subjects)
- •Current or recent history of intolerance to or avoidance of dairy of at least one month duration (by self-report and self-reported symptoms).
- •Willing to return for all study visits and complete all study related procedures
- •Able to understand and provide written informed consent in English
排除标准
- •• Currently pregnant
- •Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
- •History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty [Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded]
- •Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.
- •Active ulcers, or history of severe ulcers
- •Diabetes mellitus (type 1 and type 2)
- •Congestive Heart Failure (CHF)
- •Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- •Recent use of systemic antibiotics defined as use within 30 days prior to screening
- •Any of the following: Worked with metal (grinding, fabrication, etc.) or had an injury to the eye involving a metallic object (e.g., metallic slivers, foreign body, been injured by a metallic object that may NOT have been completely removed (e.g., bullets, shrapnel, BBs), had a reaction to a contrast medium used for MRI or CT, have claustrophobia (fear of closed places), been diagnosed with epilepsy/seizure, any reason you would be unable to remain still for long periods of time, Cardiac pacemaker, Any type of prosthesis (eye, penile), Implanted cardiac defibrillator, Heart valve prosthesis/stents, Aneurysm clip, Shunt (spinal/intraventricular), Neuro or Bone Stimulator, Wire sutures or surgical staples, Insulin or Infusion Pump, Bone/joint pin, screw, nail, plate, Implanted drug infusion device, Body tattoos, Cochlear, otologic or ear implant, Tattooed makeup (eyeliner, lip, etc.), Prostate radiation seeds, Breast tissue expander, IUD (intrauterine device), Hearing aids, Transdermal medicine patch (Nitro),Body piercing(s), Any metallic implants or objects, any other reason the participant thinks they would not be a good candidate for MRI.
- •Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance
结局指标
主要结局
Volume of milk in stomach/gastric transit
时间窗: 2 hours
Volume of milk in the stomach will be calculated using FSL software with MRI images acquired at 0, 10, 30, 60 and 120 minutes.
次要结局
- Difference in abdominal pain(2 hours)
研究者
Dennis A. Savaiano
Professor
Purdue University