Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

Federal University of Mato Grosso

Status: Enrolling

Conditions: Ketosis; Acute-Phase Response; Insulin Resistance

Treatments: Dietary Supplement: Fast; Dietary Supplement: CHO; Dietary Supplement: CHO+WP

Study type: Interventional

Funder types: Other

Identifiers

NCT05656339

42481121.3.0000.5692

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

12 hours Fast - Fast Group

Sham Comparator group

Description:

Participants will proceed in 12 hours fast condition for blood collection for laboratory assays

Treatment:

Dietary Supplement: Fast

Carbohydrate plus whey protein supplement - CHO+WP group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: CHO+WP

Carbohydrate supplement - CHO group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: CHO