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| Name | Class |
|---|---|
| Univag Centro Universitário | OTHER |
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This study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response
The investigators will enroll young male healthy volunteers. In this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (CHO+WP; n=30); or b) 200ml of water plus maltodextrin (CHO group, n=30); or c) remained fasting (Fast group; n=30). Blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in Fast group) for blood glucose; glycated hemoglobin; serum insulin; C-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. After a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. Group CHO+P will drink a clear non-residual supplement (698 mOsm/L) having 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with a "lemon tea" flavor (Nutren Fresh; Nestlé, São Paulo, Brazil). The formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); Group CHO will received a clear supplement containing 200 mL of water combined with unflavored 25 g of 100% maltodextrin (CarboCH - Prodiet, Curitiba, Brazil) at 12.5% dilution (101 mOsm/kg; 95kcal/200ml). The third group (Fast group; n=10) will not consume any food or supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 hours Fast - Fast Group | Sham Comparator | Participants will proceed in 12 hours fast condition for blood collection for laboratory assays |
|
| Carbohydrate plus whey protein supplement - CHO+WP group | Active Comparator | After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates plus whey protein. After 3 hours of ingesting the supplement blood samples will be collected again |
|
| Carbohydrate supplement - CHO group | Placebo Comparator | After 12 hours fast participants will collect blood samples and immediately will drink an oral supplement containing carbohydrates alone without whey protein. After 3 hours of ingesting the supplement blood samples will be collected again |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHO+WP | Dietary Supplement | Oral supplement containing carbohydrates plus whey protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum hydroxy butyrate | Serum hydroxy butyrate levels from 12 hours fast at 3 hours after ingestion of oral supplement | Change from 12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement |
| Change in acute phase response proteins | Change of serum C reactive protein and albumin from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement | Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement |
| Change in insulin resistance | Change of HOMA index from 12 hours fast (baseline) to 3 hours after ingestion of the oral supplement | Change from12 hours fasting (baseline) at 3 hours after the ingestion of the oral supplement |
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Inclusion Criteria:
Exclusion Criteria: or will be excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Nascimento, MD, PhD | Contact | +5565999815388 | jose.aguilar@univag.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Jose E Nascimento, MD, PhD | Univag Centro Universitário | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitário de Varzea Grande (UNIVAG) | Recruiting | Várzea Grande | Mato Grosso | 78.118-000 | Brazil |
IPD will be shared with researchers that contact with the investigator
1 year
email do jose.aguilar@univag.edu.br
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000210 | Acute-Phase Reaction |
| D007333 | Insulin Resistance |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Male volunteers, aged between 18 and 27 years, healthy, with no report of acute illness during 3 months prior to the study will be included. Individuals with obesity (calculated body mass index above 30 kg/m2), those who reported consumption of alcoholic beverages or any nutritional supplement during the study period will be excluded. The 30 selected volunteers will be scheduled to came to the laboratory after an overnight fast of 12 hours. Participants in the fasting group will immediately collect blood samples. The CHO and the CHO+WP groups will drink 200 ml of the respective supplements described above. After an interval of three hours after ingestion of the supplement, blood samples will be collected again for biochemical assays.
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Outcomes Assessor will not know the randomization nor the phases of the study.
| CHO | Dietary Supplement | Oral supplement containing carbohydrates |
|
| Fast | Dietary Supplement | Fast condition of 12 hours |
|
| D007249 |
| Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |