The Effect of a Plant-based, Protein-dense Sauce on Essen... | NCT06965699

Studies
The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults

NCT06965699

Sponsor

University of Exeter

Status

Recruiting

Last Update Posted

Sep 23, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Malnutrition Elderly
Protein Malnutrition

Interventions

ProSauce
low-protein sauce

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2025Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Apr 23, 2025

First Submission Date that Met QC Criteria

May 1, 2025

First Posted Date

May 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2025

Last Update Posted Date

Sep 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to determine whether meals fortified with plant-based high protein sauce (ProSauce) provide better metabolic availability of essential amino acids compared to meals with standard lower-protein sauce without resulting in excessive gut fullness and satiety. The main questions it aims to answer are:

Does meals with high-protein sauce deliver better metabolic availability of amino acid profile? Does this high-protein sauce also not lead to excessive appetite suppression due to its liquid form? Researchers will compare high protein sauce to a commercially available standard low protein sauce.

Participants will consume two meals, either protein-fortified or standard low-protein sauce, in a randomised order with at least a one-week washout period between each meal. The investigators will collect venous blood samples over a 6-hour postprandial period to measure plasma essential (and non-essential) amino acid and insulin concentrations. The investigators will also measure appetite-related hormones from venous plasma and assess subjective appetite using a visual analogue scale, taken in parallel with the blood sample time points.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ProSauce	Experimental		Dietary Supplement: ProSauce
standard sauce	Placebo Comparator		Dietary Supplement: low-protein sauce

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProSauce	Dietary Supplement	10g additional protein from ProSauce	ProSauce

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of essential amino acids	Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.	Essential amino acid concentrations at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 180, 240, 300, 360 minutes.

Secondary Outcomes

Measure	Description	Time Frame
Concentrations of appetite-related gut hormones	Plasma appetite-related hormones i.e., acylated ghrelin, PYY, GLP-1, CCK, will be measured at certain time points via cannulation.	Appetite-related gut hormones will be measured at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 60 and over
Living independently in the community
Capacity to provide informed consent
Non-smoking (vaping is considered smoking)
No known medical conditions that might influence the study outcomes, e.g., heart disease, diabetes mellitus, obesity, disthyroidism and other endocrinopathies and renal failure
Not taking any medications that might influence the study outcomes e.g., taking anabolic steroids or corticosteroids long term
No clinically diagnosed eating disorders
No severe dislike or allergy to any of the study food
No hospitalisations in the last 6 months
Not dieting and weight stable for 3 months before the study (< 3 kg change in weight)

Exclusion Criteria:

Age < 60y
Smoking
Food allergies
Cognitive and mobility issues
Hospitalisation in the last 6 months
Known medical conditions that might influence the study outcomes
Taking medications that influence the study outcomes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhuoxiu Jin, Dr	Contact	+447529283410		z.jin3@exeter.ac.uk
Joanna Bowtell, Prof	Contact

Overall Officials

Name	Affiliation	Role
Joanna Bowtell, Prof	University of Exeter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Exeter	Recruiting	Exeter	Devon	EX44DZ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007732	Kwashiorkor

Ancestor Terms

ID	Term
D000067011	Severe Acute Malnutrition
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided