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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Exeter

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 60 and over

Living independently in the community

Capacity to provide informed consent

Non-smoking (vaping is considered smoking)

Disqualifiers

Age < 60y

Smoking

Food allergies

Cognitive and mobility issues

Trial design

Design model

Crossover

Treatments tested in this trial

  • ProSauce

    Dietary supplement

    10g additional protein from ProSauce

  • low-protein sauce

    Dietary supplement

    Commercially available standard low-protein sauce

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ProSauceExperimental treatment 1 intervention
Group B: standard saucePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentrations of essential amino acids

Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.

Time frame
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

1

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.

Time frame
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

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