A Phase 4 interventional study of Oral consumption of milk with sequence A1-A2 and Oral consumption of milk with sequence A2-A1 in Lactose Intolerance, sponsored by a2 Milk Company Ltd.. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-25.
Sponsored by a2 Milk Company Ltd. · Phase 4, Interventional, and Basic science
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.
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
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 600 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →a2 Milk Company Ltd. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Dietary Supplement: Oral consumption of milk with sequence A1-A2
Dietary Supplement: Oral consumption of milk with sequence A2-A1
Dietary Supplement: Oral consumption of milk with sequence A2-A1
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).
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).
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.
Time frame: Three hours after product intervention at each of Visit 1 and Visit 2
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.
Time frame: 1 hour and 3 hours after product intervention
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.
Time frame: baseline and 3 hours after product intervention of each of Visit 1 and Visit 2
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.
Time frame: One hour after product intervention at each of Visit 1 and Visit 2
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.
Time frame: 3 hours after product intervention of each of Visit 1 and Visit 2
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jan 2016, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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a2 Milk Company Ltd.