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In this study, the investigators want to assess the effects of a new beverage containing whey protein and glycerol (two different dosages) on hydration status in healthy adults when compared to the control (water).
This is a single-center, double-blinded, 3 arm cross-over randomized controlled study looking to enroll 45 healthy adult participants. The study will be performed at the Clinical Innovation Lab (CIL), Nestlé Research, Lausanne. Participants will be screened and randomly assigned to 1 of 6 sequences of consumption. Enrolled participants will have three visit days. They will consume one of the test products, or control at each visit and complete the study assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Product 1 | Active Comparator | Glycerol (Dose 1) and Whey Protein |
|
| Interventional Product 2 | Active Comparator | Glycerol (Dose 2) and Whey Protein |
|
| Comparator | Placebo Comparator | Water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Sodium Beverage 1 | Dietary Supplement | The first interventional product for this study is a low-sodium beverage containing Dose 1 of glycerol, whey protein, and water. It will come in a ready to drink format for the participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Retention (%) - fluid intake vs. urine output measurement | Difference in fluid retention 2 hours after intake of the study product in comparison with the control by measuring urine output in comparison to fluid intake. | From Baseline (Timepoint 0 minutes) to 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Retention (%) 1hr measure - fluid intake vs. urine output measurement | Difference in fluid retention 1 hour after intake of the study product in comparison with the control by measuring urine output in comparison to fluid intake. | From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora Schneider | Nestlé Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab, Nestlé Research | Lausanne | Switzerland |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Low Sodium Beverage 2 | Dietary Supplement | The second interventional product for this study is a low-sodium beverage containing dose 2 of glycerol, whey protein, and water. It will come in a ready to drink format for the participants. |
|
| Control (placebo) group | Other | Water |
|
| Fluid Retention (%) between interventional products - fluid intake vs. urine output measurement | Difference in fluid retention at 1hour and 2hours after intake of the study product, comparing both study products containing the different doses of glycerol. | From Baseline(Timepoint 0 minutes), to 1hr after baseline (Timepoint 60 minutes), and to 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Net Fluid Balance - fluid intake vs. urine output measurement, weighted on the scale | Net fluid balance at 1 hour and 2 hours after intake of study product, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes) to 1hr after baseline(Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Urine weight - weighted on the scale | Urine weight at 1 hour after intake and cumulative urine weight after 2 hours of intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Cumulative Urine Weight - weighted on the scale | The cumulative urine weight 2 hours after intake of the study products relative to the cumulative urine weight 2 hours after intake of the control (Beverage Hydration Index [BHI]), comparing both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes) and at 2 hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Urine Specific Gravity (USG) - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730) | USG 1 and 2 hours after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Change in USG from baseline to 1 and 2 hours - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730) | Change in USG from baseline to 1 and 2 hours after intake (delta0-60min, delta0-120min) after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Change in calculated serum osmolality - by Blood Microsampling with Tasso Device | Change in calculated serum osmolality during 30-minute and 1 hour after intake of the study products, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes), to 30min after baseline (Timepoint 30 minutes), to 1hr after baseline (Timepoint 60 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7) |
| Hydration Questionnaire Part 1 - Visual Analogue Scale (VAS) Questionnaire (From 0-10cm, 0 indicating "not at all" and 10 indicating "extremely") | Hydration Questionnaire Part 1 Visual Analogue Scale (VAS) scores at 30 minutes, 1 hour, and 2 hours after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol. | From Baseline (Timepoint 0 minutes), to 30min after baseline (Timepoint 30 minutes), to 1hr after baseline (Timepoint 60 minutes), and 2hrs after baseline (Timepoints 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7). |
| Hydration Questionnaire Part 2 - Visual Analogue Scale (VAS) Questionnaire (Scale 0-10 cm, 0 indicating the worst score and 10 indicating the best score) | Hydration Questionnaire Part 2 ratings, comparing the study products with the control, and between both study products containing different doses of glycerol. | 5 minutes after Baseline (Timepoint 5 minutes), at 2 hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7). |
| Safety and Tolerability - Beverage Tolerability Questionnaire (Scale of 1-4, 1 indicating no symptoms and 4 indicating severe symptoms) | Comparison of Beverage Tolerability Questionnaire (BTQ): individual score and composite score between control and study products, and between both study products containing different doses of glycerol. | Prior to Baseline (Upon arrival on-site, before product intake), and at 2 hours after baseline (Timepoint 120 minutes), for Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7). |