Promephy - Metabolic Fate of Plant-based Proteins

NCT05669612 | Completed

• 1 other identifier: R9097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The PROMEPHY study aims to assess differences between animal versus plant-based proteins on metabolic and physiological parameters in healthy adults. It is envisaged that the results from this study will provide important and novel insights into the potential health-benefits of regular consumption of plant-based proteins. This may enable future application in products available to the consumer. The main objective of this study is to compare the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a plant-based protein mix with the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a milk protein isolate. In addition this study will aim to assess the impact of different protein sources on gut microbiota and proteome composition to determine the potential health impact of consumption of plant-based proteins.

Conditions

Amino Acid Change; Gastrointestinal Dysfunction

Keywords

Protein; Amino acids; Microbiota

Outcome Measures

Primary Outcomes (1)

• Amino acid Profile

  Measurement of essential amino acids (EAA; umol/L) area under the curve (iAUC) after two weeks of study product intake of plant based protein mix vs dairy protein mix

  Change from beginning (day 1) to end of each trial (day 14)

Secondary Outcomes (3)

• Uremic blood markers

  Change from beginning (day 1) to end of each trial (day 14)

• Microbiota profile

  Change from beginning (day 1) to end of each trial (day 14)

• Proteome data

  Change from beginning (day 1) to end of each trial (day 14)

Study Arms (4)

Dairy based protein

ACTIVE COMPARATOR

Milk protein isolate For bioavailability sessions: 20 grams of protein dissolved in water 200 ml water Then 50g per day (2 x 25g serves dissolved in 200 ml water) over 2 weeks

Dietary Supplement: Dairy based protein

Mixed protein

EXPERIMENTAL

Milk and plant based protein mix For bioavailability sessions: 20 grams of protein dissolved in water 200 ml water Then 50g per day (2 x 25g serves dissolved in 200 ml water) over 2 weeks

Dietary Supplement: Mixed protein

Plant-based protein 1

EXPERIMENTAL

Plant based protein mix For bioavailability sessions: 20 grams of protein dissolved in water 200 ml water Then 50g per day (2 x 25g serves dissolved in 200 ml water) over 2 weeks

Dietary Supplement: Plant-based protein 1

Plant-based protein 2

EXPERIMENTAL

Plant based protein mix with fiber For bioavailability sessions: 20 grams of protein dissolved in water 200 ml water Then 50g per day (2 x 25g serves dissolved in 200 ml water) over 2 weeks

Dietary Supplement: Plant-based protein 2

Interventions

Dairy based protein DIETARY_SUPPLEMENT

Initial bioavailability trial, followed by 2 weeks consumption of product and follow up bioavailability trial

Dairy based protein

Mixed protein DIETARY_SUPPLEMENT

Initial bioavailability trial, followed by 2 weeks consumption of product and follow up bioavailability trial

Mixed protein

Plant-based protein 1 DIETARY_SUPPLEMENT

Initial bioavailability trial, followed by 2 weeks consumption of product and follow up bioavailability trial

Plant-based protein 1

Plant-based protein 2 DIETARY_SUPPLEMENT

Initial bioavailability trial, followed by 2 weeks consumption of product and follow up bioavailability trial

Plant-based protein 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 and ≤ 50 years
• Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
• Written informed consent
• Willingness and ability to comply with the protocol
• Willingness to use a method of birth control during participation in the study (women only)
• Judged by the investigator to be in good health

You may not qualify if:

• Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.
• Known cardiovascular disease, disease related to the immune system and/or the respiratory system
• Known renal or hepatic failure or known thyroid dysfunction
• Known Diabetes Mellitus type I or type II
• Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment
• Haemoglobin (Hb) in men \<7.5 mmol/l and in women \<7.0 mmol/l at screening
• Any known bleeding disorder
• Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, anticoagulants within 3 weeks of Visit 1
• Use of antibiotics within 3 months prior to Visit 1
• Known lactose intolerance or known plant-based protein allergy
• Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/high protein diet or a weight loss program)
• Use of any nutritional supplements or additional protein supplements or nutritional support within 6 weeks prior to visit 1
• Regular heavy and/or extreme exercise (e.g. trained elite athletes) in opinion of the investigator
• Known pregnancy and/or lactation (women only)
• Current smoking or stopped smoking for \< 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month) and willingness to stop entirely during study participation (after enrolment).

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

Anglia Ruskin University

Cambridge, Cambridgeshire, CB1 1PT, United Kingdom

Location

Related Publications (5)

• Blachier F, Beaumont M, Portune KJ, Steuer N, Lan A, Audebert M, Khodorova N, Andriamihaja M, Airinei G, Benamouzig R, Davila AM, Armand L, Rampelli S, Brigidi P, Tome D, Claus SP, Sanz Y. High-protein diets for weight management: Interactions with the intestinal microbiota and consequences for gut health. A position paper by the my new gut study group. Clin Nutr. 2019 Jun;38(3):1012-1022. doi: 10.1016/j.clnu.2018.09.016. Epub 2018 Sep 20.

  PMID: 30274898 BACKGROUND

• Windey K, De Preter V, Verbeke K. Relevance of protein fermentation to gut health. Mol Nutr Food Res. 2012 Jan;56(1):184-96. doi: 10.1002/mnfr.201100542. Epub 2011 Nov 25.

  PMID: 22121108 BACKGROUND

• Beaumont M, Portune KJ, Steuer N, Lan A, Cerrudo V, Audebert M, Dumont F, Mancano G, Khodorova N, Andriamihaja M, Airinei G, Tome D, Benamouzig R, Davila AM, Claus SP, Sanz Y, Blachier F. Quantity and source of dietary protein influence metabolite production by gut microbiota and rectal mucosa gene expression: a randomized, parallel, double-blind trial in overweight humans. Am J Clin Nutr. 2017 Oct;106(4):1005-1019. doi: 10.3945/ajcn.117.158816. Epub 2017 Sep 13.

  PMID: 28903954 RESULT

• David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

  PMID: 24336217 RESULT

• Liu J, Klebach M, Visser M, Hofman Z. Amino Acid Availability of a Dairy and Vegetable Protein Blend Compared to Single Casein, Whey, Soy, and Pea Proteins: A Double-Blind, Cross-Over Trial. Nutrients. 2019 Nov 1;11(11):2613. doi: 10.3390/nu11112613.

  PMID: 31683779 RESULT

Study Officials

• Justin Roberts, PhD

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Protein supplements will be provided in a randomized, double-blinded manner. Both the participants and research testers will be masked from knowing the specifics of the supplement intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to each of 4 protein-related products in a double-blind, crossover, single centre study

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: May 2, 2023
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)