NCT06272331

Brief Summary

The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study. The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks. Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

February 9, 2024

Last Update Submit

July 26, 2024

Conditions

Food Digestion

Keywords

Plant-based drinkMilkPostprandial plasma responseMRI

Outcome Measures

Primary Outcomes (1)

  • Postprandial plasma amino acid profile as characterized by the peak height and iAUC

    Change in postprandial plasma amino acid profile over time

    5 hours

Secondary Outcomes (2)

  • Gastric behavior

    2 hours

  • Postprandial plasma response

    5 hours

Other Outcomes (2)

  • Verbal ratings of wellbeing

    5 hours

  • MRI markers of digestion

    2 hours

Study Arms (3)

Low-protein plant-based drink

OTHER

Ingestion of a low-protein plant-based drink.

Other: Low-protein plant-based drink

High-protein plant-based drink

OTHER

Ingestion of a high-protein plant-based drink

Other: High-protein plant-based drink

Cow's milk

OTHER

Ingestion of cow's milk.

Other: Cow's milk

Interventions

Low-protein plant-based drinkOTHER

Ingestion of a low-protein plant-based drink

Low-protein plant-based drink
High-protein plant-based drinkOTHER

Ingestion of a high-protein plant-based drink

High-protein plant-based drink
Cow's milkOTHER

Ingestion of cow's milk

Cow's milk

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 18 - 45 y
  • Apparently healthy (self-reported)
  • Normal-weight (BMI 18.5 - 25 kg/m2)
  • Willing to be informed about incidental findings of pathology
  • Willing to comply with the study procedures

You may not qualify if:

  • Allergy or intolerance for cow milk, lactose or gluten (self-reported)
  • Gastric disorders or regular gastric complaints, for example heart burn
  • Use of medication which alters the normal functioning of the stomach, such as:
  • Medical drug use that influences the GI tract's normal function, e.g. motility, pH etc.: among others use of protein pump inhibitors, antacids, anti-depressants etc. (judged by study doctor)
  • Medical drug use that influences the GI tract's microbiota: antibiotic use within one month prior to the pre-study screening day (judged by study doctor)
  • Following a vegan diet
  • Smoking (\>2 cigarettes a week)
  • Having a chronic illness that could affect food digestion and nutrient absorption including but not limited to kidney disease, thyroid disease and diabetes mellitus (self-reported)
  • Alcohol consumption of more than 14 glasses/week
  • Having given a blood donation in the past two months
  • Hb value below 8.5 mmol/L (as measured with finger-prick method at screening)
  • Having a contra-indication to MRI scanning, including, but not limited to:
  • Pacemakers and defibrillators
  • Intraorbital or intraocular metallic fragments
  • Ferromagnetic implants
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Research Unit - Division of Human Nutrition and Health

Wageningen, 6708WE, Netherlands

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Paul Smeets, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 22, 2024

Study Start

February 6, 2024

Primary Completion

July 24, 2024

Study Completion

July 24, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)