Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.
Gut inflammation is reflected by serum C-Reactive Protein (CRP), hemoglobin (HB), interleukin-4 (IL-4), Immunoglobulin G (IgG), Immunoglobulin E (IgE), Immunoglobulin G1 (IgG1), Immunoglobulin G2a (IgG2a), β-Casomorphin-7 (BCM-7), Glutathione, calcium (Ca), iron (Fe) and zinc (Zn) concentration; gastrointestinal (GI) symptoms are measured via Visual Analog Scale (VAS) for gut tolerance, including borborygmus, bloating, break wind, abdominal pain, and diarrhea; behavioral well-being is assessed using Subtle Cognitive Impairment Test (SCIT).
The total duration of study was 24 weeks, including subject enrollment, study intervention, laboratory testing, and providing clinical study report. The cross-over study consisted of 5 days of each product intervention; 10 days of wash-out in phase 1 and phase 2, respectively; and then followed by 6 weeks of statistical analysis and clinical report completion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A1-A2 | Experimental | Oral consumption of milk A1 in study phase 1. Oral consumption of milk A2 in study phase 2. |
|
| Sequence A2-A1 | Experimental | Oral consumption of milk A2 in study phase 1. Oral consumption of milk A1 in study phase 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral consumption of milk A1 in study phase 1 | Dietary Supplement | Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of gastrointestinal symptom VAS scores | were self-measured by study subjects on a scale from 0 (never) to 3 (always) at baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption) and at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2). | Baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption), at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | In each study phase, the number of defecation per day measured during the last 5 days of wash-out period (day -4, -3, -2, -1, 0 in phase 1 and day 10, 11, 12, 13, 14 in phase 2) and the 5 days of product intervention (day 1, 2, 3, 4, 5 in phase 1 and day 15, 16, 17, 18, 19 in phase 2). | Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sprim (Shanghai) Consulting Co., Ltd. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31305326 | Derived | Sheng X, Li Z, Ni J, Yelland G. Effects of Conventional Milk Versus Milk Containing Only A2 beta-Casein on Digestion in Chinese Children: A Randomized Study. J Pediatr Gastroenterol Nutr. 2019 Sep;69(3):375-382. doi: 10.1097/MPG.0000000000002437. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral consumption of milk A2 in study phase 1 | Dietary Supplement | Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 1. |
|
| Oral consumption of milk A1 in study phase 2 | Dietary Supplement | Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 2. |
|
| Oral consumption of milk A2 in study phase 2 | Dietary Supplement | Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 2. |
|
| Stool consistency | In each study phase, the score of stool consistency assessed using Bristol Stool Chart during the last 5 days of wash-out period (day -4, -3, -2, -1, 0 in phase 1 and day 10, 11, 12, 13, 14 in phase 2) and the 5 days of product intervention (day 1, 2, 3, 4, 5 in phase 1 and day 15, 16, 17, 18, 19 in phase 2). | Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 5, 16, 17, 18, 19 |
| Serum C-reactive protein (CRP) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Hemoglobin (HGB) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Interleukin-4 (IL-4) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Immunoglobulin G (IgG) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Immunoglobulin E (IgE) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Immunoglobulin G1 (IgG1) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Immunoglobulin G2a (IgG2a) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum β-Casomorphin-7 (BCM-7) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum Glutathione concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum calcium (Ca) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum iron (Fe) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Serum zinc (Zn) concentration | Only measured in phase 1 | Day 1 before intervention (baseline), and day 5 (post-intervention) |
| Fecal short chain fatty acids (SCFA) concentration | Measured at baseline and post-intervention in each study phase | Day 1, Day 5, Day 15, Day 19 |
| myeloperoxidase (MPO) | Measured at baseline and post-intervention in each study phase | Day 1, Day 5, Day 15, Day 19 |
| Subtle Cognitive Impairment Test (SCIT) | Subject response time and error rate at stimulus exposure duration of 16, 32, 48, 64, 80, 96, 112 and 128 millisecond, as well as their head and tail means were recorded at baseline (day 1 for phase 1 and day 15 for phase 2) and the end of intervention (day 5 for phase 1 and day 19 for phase 2). | 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 1; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 5; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 15; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 19 |