Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

A

a2 Milk

Status and phase

Completed
Phase 4

Conditions

Lactose Intolerance

Treatments

Dietary Supplement: Oral consumption of milk with sequence A2-A1
Dietary Supplement: Oral consumption of milk with sequence A1-A2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02878876
15-SC-11-A2-004

Details and patient eligibility

About

This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.

Full description

Study sites: Shanghai, Guangzhou, Beijing Eligible subjects were enrolled in the study and randomized into one of the 2 study arms: Sequence A1-A2: Oral consumption of milk containing both A1 and A2 type beta casein at Visit 1 and milk containing only A2 type beta casein at Visit 2; Sequence A2-A1: Oral consumption of milk containing only A2 type beta casein at Visit 1 and milk containing both A1 and A2 type beta casein at Visit 2. Washout period: 2 weeks between Visit 1 and Visit 2

Enrollment

600 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 20~50 years old male or female subjects;
  • Non-regular milk drinker with self-reported intolerance to commercial milk;
  • Suffered from mild to moderate digestive discomfort after milk consumption;
  • Have normal electrocardiograms (ECG) and blood pressure during quiet respiration;
  • Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
  • Be willing to comply with all the requirements and procedures of the study;
  • Agree to sign the informed consent form;
  • Agree not to enroll in another interventional clinical research study while participating in this study;
  • Fully understand the nature, objective, benefit and the potential risks and side effects of the study.

Exclusion criteria

  • Female on pregnant or feeding;
  • Have known dairy allergy;
  • Have severe response to milk intolerance;
  • Have history of faecal impaction;
  • Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ;
  • Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
  • Currently taking medicines for cardiovascular or metabolic disease;
  • Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
  • Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
  • Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
  • Had hospitalizations within 3 months before screening;
  • Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

600 participants in 2 patient groups

Sequence A1-A2
Experimental group
Description:
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Treatment:
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Sequence A2-A1
Experimental group
Description:
Dietary Supplement: Oral consumption of milk with sequence A2-A1
Treatment:
Dietary Supplement: Oral consumption of milk with sequence A2-A1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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