Lactose Intolerance
Conditions
Brief summary
The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
Interventions
OTHERFermented infant milk formula
OTHERNon-fermented infant milk formula
Sponsors
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
BMI between 18.5 and 24.9 kg/m2 inclusive Lactose intolerant The following criteria need to be checked at visit 2: * Lactose intolerance confirmed by positive Hydrogen Breath Test (HBT) (i.e. if there are two or more samples with hydrogen level \> 20 ppm increase compared to baseline sample between 90 mins and 240 min sampling time point). * At least one sample with hydrogen level \> 20 ppm increase compared to baseline between 90 mins and 180 mins sampling time point.
Exclusion criteria
History of gastrointestinal disorders Current illness which could interfere with the study (e.g. diarrhea, regurgitation) Any history of cow's milk protein allergy or known allergy to galacto-oligosaccharides Any current participation or within 8 weeks of study start, in any other study involving investigational or marketed products, any medical procedures, or any surgical methods. Any antibiotic, laxative or colonic cleansing treatments within 4 weeks of study start Any administration of probiotic in the 1 week prior to study start Investigator's uncertainty about willingness or ability of subject to comply with protocol requirements The following criteria need to be checked at visit 2: * Level of hydrogen \> 20 ppm in the baseline breath sample. * An early peak of hydrogen (i.e. hydrogen level \> 20 ppm increase compared to baseline value) in the first 60 minutes after ingestion of the study products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log of First Postprandial Peak Change of Hydrogen Concentration | Postprandial peak hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4 | This is measured as the log of the first change \>20ppm peak value compared to baseline between 90 minutes and 240 minutes. If there was no change \>20ppm at all between 90 minutes and 240 minutes, it is the maximum change compared to baseline in that interval |
| Log of Maximum Postprandial Change in Hydrogen Concentration | Maximum postprandial hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4 | This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes | Hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 30, 60, 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4 | The iAUC of hydrogen concentration from 30 to 240 minute sampling time points is calculated with the triangular rule (reference: Wolever TM. Effect of blood sampling schedule and method of calculating the area under the curve on validity and precision of glycaemic index values. Br J Nutr. 2004 Feb;91(2):295-301). The square root of the iAUC is then taken for the outcome measure |
Countries
Singapore
Participant flow
Pre-assignment details
Two subjects were terminated before randomisation (1 due to sponsor decision to withdraw, and 1 due to consent withdrawal).
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 Test at visit 3, Control at visit 4 | 14 |
| Sequence 2 Control at visit 3, Test at visit 4 | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Age, Continuous | 30.0 years STANDARD_DEVIATION 6.5 | 30.6 years STANDARD_DEVIATION 4.6 | 30.3 years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized Chinese | 13 Participants | 12 Participants | 25 Participants |
| Race/Ethnicity, Customized Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Malay | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 26 / 27 | 25 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
Log of First Postprandial Peak Change of Hydrogen Concentration
This is measured as the log of the first change \>20ppm peak value compared to baseline between 90 minutes and 240 minutes. If there was no change \>20ppm at all between 90 minutes and 240 minutes, it is the maximum change compared to baseline in that interval
Time frame: Postprandial peak hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
Population: At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Log of First Postprandial Peak Change of Hydrogen Concentration | Baseline | 1.21 log(ppm) | Standard Error 0.1 |
| Control | Log of First Postprandial Peak Change of Hydrogen Concentration | Post-baseline | 3.38 log(ppm) | Standard Error 0.08 |
| Test | Log of First Postprandial Peak Change of Hydrogen Concentration | Baseline | 1.10 log(ppm) | Standard Error 0.1 |
| Test | Log of First Postprandial Peak Change of Hydrogen Concentration | Post-baseline | 3.59 log(ppm) | Standard Error 0.09 |
p-value: 0.080195% CI: [-0.04, 0.67]Mixed Models Analysis
Primary
Log of Maximum Postprandial Change in Hydrogen Concentration
This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes
Time frame: Maximum postprandial hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
Population: At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Log of Maximum Postprandial Change in Hydrogen Concentration | Baseline | 1.21 log(ppm) | Standard Error 0.1 |
| Control | Log of Maximum Postprandial Change in Hydrogen Concentration | Post-baseline | 3.70 log(ppm) | Standard Error 0.1 |
| Test | Log of Maximum Postprandial Change in Hydrogen Concentration | Baseline | 1.09 log(ppm) | Standard Error 0.11 |
| Test | Log of Maximum Postprandial Change in Hydrogen Concentration | Post-baseline | 3.93 log(ppm) | Standard Error 0.11 |
p-value: 0.071495% CI: [-0.03, 0.71]Mixed Models Analysis
Secondary
Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes
The iAUC of hydrogen concentration from 30 to 240 minute sampling time points is calculated with the triangular rule (reference: Wolever TM. Effect of blood sampling schedule and method of calculating the area under the curve on validity and precision of glycaemic index values. Br J Nutr. 2004 Feb;91(2):295-301). The square root of the iAUC is then taken for the outcome measure
Time frame: Hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 30, 60, 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
Population: At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes | 66.22 sqrt(ppm*min) | Standard Error 4.42 |
| Test | Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes | 75.78 sqrt(ppm*min) | Standard Error 4.59 |
p-value: 0.060995% CI: [-0.48, 19.6]Mixed Models Analysis