Back to resultsIncidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Primary Purpose
Lactose Intolerance
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oral consumption of milk with sequence A1-A2
Oral consumption of milk with sequence A2-A1
Sponsored by
About this trial
This is an interventional basic science trial for Lactose Intolerance
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A1-A2
Sequence A2-A1
Arm Description
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Dietary Supplement: Oral consumption of milk with sequence A2-A1
Outcomes
Primary Outcome Measures
Gastrointestinal Symptom VAS scores at 3 hours
Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 3 hours after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 3-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
Secondary Outcome Measures
The percentage of improvement in gastrointestinal symptoms after drinking A2 versus A1
The improvement in gastrointestinal symptoms after drinking A2 versus A1 were classified into 4 mutually exclusive categories according to the following definition:
No symptom: have no gastrointestinal symptoms after drinking product A2 while having symptoms after drinking product A1.
Significant improvement: still have gastrointestinal symptom after drinking product A2, the reduction of symptom scores >3
Slight improvement: still have gastrointestinal symptom after drinking product A2, 1<=reduction of symptom scores<=3
No difference (not improved or worsen): reduction of symptom scores<=0
The frequency and percentage in each category of improvement for each single gastrointestinal symptom, as well as that for all symptoms, are summarized.
Urinary galactose concentration
Urinary galactose (U-gal) concentration was measured at baseline and 3-hour of each of Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with fixed effects of study product (A1 or A2) and study visit (1 or 2) and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
The U-gal measurements over the whole study period (both Visit 1 and Visit 2) for all subjects were also summarized by study product. Product difference was evaluated using one-way ANOVA.
Gastrointestinal Symptom VAS scores at 1 hour
Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 1 hour after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 1-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
Change of urinary galactose concentration from baseline at 3 hours <0.27 mmol/L (Yes/No)
Based on the results of urinary galactose test, subjects were classified as lactose malabsorbers if they had an increase in urinary galactose concentration of <0.27 mmol/L at 3 hours after oral consumption of 15g lactose (corresponding to 300 ml of product A1). And those with an increase in urinary galactose concentration of ≥0.27 mmol/L at 3-hour were classified as lactose absorbers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02878876
Brief Title
Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Official Title
Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
a2 Milk Company Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A1-A2
Arm Type
Experimental
Arm Description
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Arm Title
Sequence A2-A1
Arm Type
Experimental
Arm Description
Dietary Supplement: Oral consumption of milk with sequence A2-A1
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral consumption of milk with sequence A1-A2
Intervention Description
Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral consumption of milk with sequence A2-A1
Intervention Description
Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).
Primary Outcome Measure Information:
Title
Gastrointestinal Symptom VAS scores at 3 hours
Description
Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 3 hours after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 3-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
Time Frame
Three hours after product intervention at each of Visit 1 and Visit 2
Secondary Outcome Measure Information:
Title
The percentage of improvement in gastrointestinal symptoms after drinking A2 versus A1
Description
The improvement in gastrointestinal symptoms after drinking A2 versus A1 were classified into 4 mutually exclusive categories according to the following definition:
No symptom: have no gastrointestinal symptoms after drinking product A2 while having symptoms after drinking product A1.
Significant improvement: still have gastrointestinal symptom after drinking product A2, the reduction of symptom scores >3
Slight improvement: still have gastrointestinal symptom after drinking product A2, 1<=reduction of symptom scores<=3
No difference (not improved or worsen): reduction of symptom scores<=0
The frequency and percentage in each category of improvement for each single gastrointestinal symptom, as well as that for all symptoms, are summarized.
Time Frame
1 hour and 3 hours after product intervention
Title
Urinary galactose concentration
Description
Urinary galactose (U-gal) concentration was measured at baseline and 3-hour of each of Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with fixed effects of study product (A1 or A2) and study visit (1 or 2) and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
The U-gal measurements over the whole study period (both Visit 1 and Visit 2) for all subjects were also summarized by study product. Product difference was evaluated using one-way ANOVA.
Time Frame
baseline and 3 hours after product intervention of each of Visit 1 and Visit 2
Title
Gastrointestinal Symptom VAS scores at 1 hour
Description
Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 1 hour after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 1-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
Time Frame
One hour after product intervention at each of Visit 1 and Visit 2
Title
Change of urinary galactose concentration from baseline at 3 hours <0.27 mmol/L (Yes/No)
Description
Based on the results of urinary galactose test, subjects were classified as lactose malabsorbers if they had an increase in urinary galactose concentration of <0.27 mmol/L at 3 hours after oral consumption of 15g lactose (corresponding to 300 ml of product A1). And those with an increase in urinary galactose concentration of ≥0.27 mmol/L at 3-hour were classified as lactose absorbers.
Time Frame
3 hours after product intervention of each of Visit 1 and Visit 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Clarke, PhD
Organizational Affiliation
a2 Milk Company Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29070042
Citation
He M, Sun J, Jiang ZQ, Yang YX. Effects of cow's milk beta-casein variants on symptoms of milk intolerance in Chinese adults: a multicentre, randomised controlled study. Nutr J. 2017 Oct 25;16(1):72. doi: 10.1186/s12937-017-0275-0.
Results Reference
derived
Learn more about this trial
Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
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