NCT06465004

Brief Summary

A pilot study is being conducted to compare a new plant-based protein drink to commercially available animal-based protein drinks. The goal is to assess if the plant-based drink delivers amino acids to the bloodstream as effectively as the animal-based drinks, potentially offering a viable option for those on plant-based diets. The study will involve approximately 12 healthy adults aged 18-40. Each participant will try all three drinks (the new plant-based drink, a commercial animal-based drink, and another animal-based recipe) on separate days in a randomized order. Before and after (30, 60, and 90 minutes) consuming each drink, a small blood sample will be drawn to measure amino acid levels (leucine). By comparing the results, the investigators hope to determine if the plant-based drink can match the effectiveness of animal-based protein drinks in delivering essential nutrients. This research could contribute to the development of sustainable and nutritious plant-based protein alternatives.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

20 days

First QC Date

June 13, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

LeucinPlant-basedAnimal-basedBioavailability

Outcome Measures

Primary Outcomes (1)

  • leucine content in the blood

    Assessment of leucine content in blood before and 30-60-90 min after consumption of drink

    4 hours

Study Arms (3)

Animal-based A

ACTIVE COMPARATOR

A commercially available high protein drink, based on animal proteins (Fresubin Protein Energy)

Dietary Supplement: Consumption of protein - rich drink

Animal-based B

ACTIVE COMPARATOR

A homemade drink containing animal-based proteins, using a specific animal-based protein isolate mix.

Dietary Supplement: Consumption of protein - rich drink

Plant-based A

ACTIVE COMPARATOR

A homemade drink containing plant-based proteins, formulated to have the same macronutrient content as the animal-based drinks.

Dietary Supplement: Consumption of protein - rich drink

Interventions

The participants will drink on of three protein - rich drinks

Animal-based AAnimal-based BPlant-based A

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gender: male and female
  • Age: 18-40 years
  • Signed written informed consent

You may not qualify if:

  • Smoking history
  • Cardiovascular diseases
  • BMI \> 35 kg/m2
  • Caffeine consumption \< 1 day before the study participation
  • Allergies: Soy, Peas, Milk, Lactose, Fructose
  • High intensity exercise \<2 days before study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SLA - ETH Zurich

Schwerzenbach, Canton of Zurich, 8603, Switzerland

RECRUITING

Study Officials

  • Gommaar D'Hulst, PhD

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gommaar D'Hulst, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized cross-over design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

June 8, 2024

Primary Completion

June 28, 2024

Study Completion

August 30, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations