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| ID | Type | Description | Link |
|---|---|---|---|
| 1792-23P | Other Grant/Funding Number | The Dairy Alliance |
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The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which the physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored.
Dairy provides essential nutrients and dairy products and are among the best quality and bioavailable protein sources available to humans. Milk protein allergy is extremely rare outside of childhood, and lactose intolerance is highly variable among ethnicities. Nonetheless, many adults avoid fluid milk and dairy products unnecessarily. Recent studies suggest that dairy intolerant individuals are having gastrointestinal reactions specifically to the bioactive metabolites (specifically, beta-casomorphin-7[BCM-7]) of casein protein subtype A1, and consuming milk void of A1 and rich in A2 casein alleviates symptoms.
The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored. Enrollment assessments will include a comprehensive metabolic panel, diet history, and medical history questionnaires. Stool samples will be collected at the beginning and end of each of the 3 test phases (6 total samples per participant). Each test phase will last 6 days long, during which participants will receive increased doses of casein every 2 days.
On Day 1, participants will receive 50mg casein/kg/bw (~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (~500ml milk). During test phases, breath hydrogen and methane will be measured every thirty minutes for three hours, and blood glucose will be measured every thirty minutes for two hours. Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours. There will be a 7-10 day wash out period in between test phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional lactose-free milk first | Experimental | Participants will consume conventional lactose-free milk first, then each of the other milk types in random order |
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| Non-conventional (A2) lactose-free milk first | Experimental | Participants will consume non-conventional (A2) lactose-free milk first, then each of the other milk types in random order |
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| Non-conventional (A2) milk first | Experimental | Participants will consume non-conventional (A2) milk first, then each of the other milk types in random order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional lactose-free cow's milk | Other | Participants will receive conventional lactose-free cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (~500ml milk). During test phases, breath hydrogen and methane will be measured every thirty minutes for three hours, and blood glucose will be measured every thirty minutes for two hours. Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours. There will be a 7-10 day wash out period in between test phases. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Distress Scores | Changes in gastrointestinal distress measured via visual analog scales that range from 0 (no symptoms) to 100 cm (severe symptoms). Lower values are optimal. | 24 hours after each sample challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Breath Hydrogen (ppm) | Breath hydrogen will be measured via QuinTron BreathTracker SC Analyzer every 30 minutes for three hours beginning immediately prior to each sample challenge. Lower levels are optimal. | Three hours after each sample challenge |
| Breath Methane (ppm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Frugé, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36849 | United States |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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Randomized controlled, double-blinded, double-crossover trial
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| Nonconventional (A2) cow's milk | Other | Participants will receive nonconventional (A2) cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (~500ml milk). During test phases, breath hydrogen and methane will be measured every thirty minutes for three hours, and blood glucose will be measured every thirty minutes for two hours. Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours. There will be a 7-10 day wash out period in between test phases. |
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| Nonconventional (A2) lactose-free cow's milk | Other | Participants will receive nonconventional (A2) lactose-free cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (~500ml milk). During test phases, breath hydrogen and methane will be measured every thirty minutes for three hours, and blood glucose will be measured every thirty minutes for two hours. Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours. There will be a 7-10 day wash out period in between test phases. |
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Breath methane will be measured via QuinTron BreathTracker SC Analyzer every 30 minutes for three hours beginning immediately prior to each sample challenge. Lower levels are optimal. |
| Three hours after each sample challenge |
| Blood Glucose (mg/dl) | Capillary finger sticks will determine blood glucose levels for two hours beginning immediately prior to each sample challenge. Minimal deviations from baseline are optimal. | Two hours after each sample challenge |
| Stool microbiome composition | 16S changes in microbiome alpha diversity. Higher levels are optimal. | One week after each sample challenge |
| Stool Beta-casomorphin-7 (BCM-7) | Fecal samples preserved in aqueous solution will be analyzed for casein metabolite, BCM-7. Lower levels are optimal. | One week after each sample challenge |
| Stool intestinal fatty acid binding protein (I-FABP) | Fecal samples preserved in aqueous solution will be analyzed for intestinal permeability marker, I-FABP. Lower levels are optimal. | One week after each sample challenge |
| D005502 |
| Food |
| D019602 | Food and Beverages |