Nutritional Intervention Using Protein Rich Whole Food Sources Clinical Trial
— FFTOfficial title:
Assessing the Muscle Protein Synthetic Response Following the Ingestion of a Variety of Protein Rich Whole Foods Compared to an Isolated Protein Source.
| NCT number | NCT04794153 |
| Other study ID # | FFT |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 1, 2021 |
| Est. completion date | May 1, 2024 |
| Verified date | May 2024 |
| Source | University of Exeter |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background To date, most of the literature investigating the role of dietary protein in muscle growth has focused on isolated protein sources. However, dietary protein is most commonly consumed within a whole food source. Consuming dietary protein within a whole food matrix may additionally stimulate muscle growth. The idea being, there may be other components within food, capable of producing a greater response. Objectives: To assess the effect of consuming a variety of whole food sources, on the stimulation of muscle growth compared to an isolated protein source following a single bout of lower body resistance exercise. Methods Young healthy resistance-trained volunteers will consume a protein rich whole food source, following a bout of lower body resistance exercise. Stable isotope IV infusions and repeated blood and muscle samples will be taken to assess protein digestion and absorption, as well as muscle protein synthesis rates. Value of Research: To determine whether whole food sources potentiate muscle protein synthesis rates (and to what extent across whole food sources) compared to an isolated protein source. In doing so, we can further investigate the nutrients involved that may be contributing to this effect.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | May 1, 2024 |
| Est. primary completion date | April 1, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: - Males and Females - BMI 18.5 - 30 kg/m2 - Aged 18 - 40 years - Structured Resistance training consistently for > 6 months - A 5-7 day "washout" period from any supplementation Exclusion Criteria: - Age >40 years - Body mass index (BMI) <18.5 or >30 kg/m2 - Any metabolic impairments - Any cardiovascular impairments - High blood pressure (=140/90 mmHg) - Any gastrointestinal disorders - Any medications known to affect protein and/or amino acid metabolism - A personal or family history of epilepsy, seizures or schizophrenia, motor disorder - Chronic over the counter use of pharmaceuticals (> 1 month) - Allergic to any of the whole foods included in the study |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Exeter | Exeter | Devon |
| Lead Sponsor | Collaborator |
|---|---|
| University of Exeter | Marlow Foods Ltd |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postprandial Muscle protein Synthetic Response following the ingestion of a protein rich whole food source. | 84 participants will undergo a single bout of lower body exercise followed by the ingestion of one of the six protein rich whole food sources. Using stable isotope tracer methodology and muscle biopsy samples, the postprandial muscle protein synthetic response will be able to be calculated. | 2 years |