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| Name | Class |
|---|---|
| Danone Nutricia Research | INDUSTRY |
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The key research objective is to characterise the amino acid (AA) bioavailability for 4 hours following consumption of a single serving of a high protein spoonable yoghurt, compared to a micellar casein drink or a flavoured water-based placebo jelly, in 18-45-year-old males and females. An additional exploratory objective is to characterise the time to reach peak concentration (Tmax) of AA after consumption of a single serving of each product.
This study is a single-blind, three-way, randomised crossover design. It involves four visits to the laboratory in total; the first session will be a pre-screening and familiarisation, and the subsequent three sessions will be 3 x bioavailability assessments, separated by a washout period of a minimum of 5 days and maximum of 21 days. The bioavailability assessments will be identical except for the product consumed; subjects will receive one serving of the following in a random order:
A follow-up communication via telephone will be conducted within 7 days of completion of the fourth and final session to ensure there are no adverse effects of participation.
A detailed overview of the research activity that will take place in each session is provided below:
Visit 1: Pre-screening: Volunteers will receive information on the study, and they will be familiarised with the requirements for participation and provide written informed consent. Subjects will be requested to complete 3-day food and exercise diaries, comprising of 1 weekend day, 1 rest day, and 1 exercise day within a week of the trial. This will be handed in on Visit 2. Subjects' body height, body mass, body composition, and body mass index (BMI) will be measured.
Visits 2-4: Bioavailability assessments: Subjects will refrain from physical activity and alcohol consumption 24 hours before each visit and caffeine 12 hours before each visit. After an overnight fast (at least 10 hours), subjects will come to the lab to participate. Study staff will collect food and exercise diaries from subjects. If the inclusion criteria continue to be met, participants can continue into the trial. A cannula will be inserted into an antecubital vein by a qualified member of the study team, with appropriate standard procedures for cannula care followed throughout the visit duration.
Subjects will consume one serving of one of the study products (~10 minutes). Subjects Blood samples will be drawn at time (T) = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake. Throughout the study visits, subjects are not allowed to eat, but will be permitted to drink up to 250 mL of water after the first 2 hours - the volume consumed and timing during Visit 2 will be replicated as best as possible on subsequent visits. In addition, subjects will be asked to abstain from any physical exercise other than incidental walking during the study visits.
Within 5-21 days after Visit 2, volunteers will undergo the same intervention with the second and then third study products at Visits 3 and 4, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | High protein commercially available spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia). |
|
| Micellar casein drink | Active Comparator | Micellar casein drink (1 serving = 45 g protein/480 g). |
|
| Placebo | Placebo Comparator | Flavoured water-based placebo jelly (1 serving = 0 g protein comprising 3 jelly pots totalling 480 g). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product: Yoghurt | Dietary Supplement | High protein spoonable yoghurt |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration for Total Amino Acids | Descriptive summary of peak concentration (Cmax) [µM] for total AA after consumption of a single serving of a high protein spoonable yoghurt, micellar casein drink, and flavoured water-based placebo jelly in 18-45-year-old males and females over 4 hours. | At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake. |
| Incremental Area Under Curve for Total Amino Acids | Descriptive summary of incremental area under the curve (iAUC) [µM] for total AA after consumption of a single serving of a high protein spoonable yoghurt, micellar casein drink, and flavoured water-based placebo jelly in 18-45-year-old males and females over 4 hours. | At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Concentration of Amino Acids | Descriptive summary of time to reach maximum concentration (Tmax) [min] of total AA after consumption of a single serving of a high protein spoonable yoghurt, micellar casein drink, and flavoured water-based placebo jelly in 18-45-year-old males and females over 4 hours. | At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glyn Howatson | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34965513 | Result | McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29. |
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Single-Blinded
| Micellar casein drink |
| Dietary Supplement |
Micellar casein drink made from water, casein powder and fruit syrup |
|
| Placebo | Dietary Supplement | Placebo sugar free jelly |
|