Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers: A Controlled Randomized Crossover Trial

Conditions
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Ketosis, Acute-Phase Response, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: CHO+WP
* Dietary Supplement: CHO
* Dietary Supplement: Fast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male young healthy volunteers Exclusion Criteria: or will be excluded. Individuals with obesity (calculated body mass index above 30 kg/m2) Participants reporting consumption of alcoholic beverages Consumption of any nutritional supplement during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 12 hours Fast - Fast Group<br>Participants will proceed in 12 hours fast condition for blood collection for laboratory assays | Dietary Supplement: Fast<br>* Fast condition of 12 hours<br>|
| Active Comparator: Carbohydrate plus whey protein supplement - CHO+WP group<br>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 | Dietary Supplement: CHO+WP<br>* Oral supplement containing carbohydrates plus whey protein<br>|
| Placebo Comparator: Carbohydrate supplement - CHO group<br>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 | Dietary Supplement: CHO<br>* Oral supplement containing carbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketone bodies, Whey protein, Fasting