Plant-based Mince vs Beef Mince: Does One Make You Feel Fuller for Longer?

NCT04950595 | Unknown Phase 2 DMC

• 1 other identifier: VTF001
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Energy (kJ) consumed in test meals

  To determine whether a meal containing V2 plant-based meat is more satiating than an equivalent meal containing beef mince, as assessed by the energy (kJ) of the respective meals consumed to achieve fullness.

  3 hours

• Visual Analogue Scale (VAS)

  Maintenance of satiety in the post-prandial period as measured by the VAS. Participants will indicate their perceived feelings of hunger, satiety, fullness and prospective food consumption at each time point on the VAS by moving the slider bar along a 10 mm line displayed on an iPad Question 1: How hungry do you feel? Answers to question 1: Please indicate how you are feeling at this moment by moving the slider bar to the appropriate point on each scale below (I am not hungry at all\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_I have never been more hungry) Question 2: How satisfied do you feel? Answer to Q 2: I am completely empty\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_I cannot eat another bite. Question 3: How full do you feel? Anwer to Q3: Not at all full\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Totally full Question 4: How much do you think you can eat? Answer to Q4: Nothing at all\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_A lot.

  4 hours

Secondary Outcomes (6)

• Energy consumed at subsequent buffet meal (kJ)

  4 hours

• Glucose (mmol/L) (plasma biomarker)

  4 hours

• insulin (pmol) (plasma biomarker)

  4 hours

• ghrelin (mcg) (plasma biomarker)

  4 hours

• cholecystokinin (CCK) (plasma biomarker)

  4 hours

Study Arms (2)

Beef mince group

EXPERIMENTAL

The test meal provided at lunch will be made up of 45% beef mince, with all remaining ingredients the same as the other arm.

Other: Beef mince

Plant-based mince group

EXPERIMENTAL

The test meal provided at lunch will be made up of 45% plant-based mince, with all remaining ingredients the same as the other arm.

Other: Plant-based mince

Interventions

Plant-based mince OTHER

Spaghetti bolognaise meal made with plant-based mince

Plant-based mince group

Beef mince OTHER

Spaghetti bolognaise meal made with beef mince

Beef mince group

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male individuals
• Aged between ≥18 \& ≤56 years at informed consent
• Body mass index (BMI) ≥18.5 kg/m² and ≤27.5 kg/m² (confirmed during screening appointment)
• Weight stable for last 6 months (\< +/- 5kg change)\*
• Consume red meat regularly (at least 1 x week)
• Willing to provide written Informed Consent
• Be able to attend the CSIRO nutrition clinic for around 7 hours on two occasions across a two week period.
• Self-reported

You may not qualify if:

• Health conditions\* that could affect appetite/food intake or require a prescribed diet such as gastrointestinal diseases \[including, but not limited to diverticulitis, ulcerative colitis, Crohn's disease, or coeliac disease\], type 1 or type 2 diabetes, cancer, renal or liver diseases
• Gastrointestinal symptoms\* (i.e. pain, reflux, diarrhea, or constipation), surgeries\* (i.e. bariatric surgery such as gastric banding) or use of medications\* (i.e. appetite suppressants, steroids) known to potentially affect energy intake, appetite, or gastrointestinal motor function
• Known food allergies or intolerances to the study intervention products\^
• History of eating disorders\*
• Unable or unwilling to consume red meat
• Current smoker (or history of smoking within the last six months)
• History of or known presence of alcohol abuse or illicit drug use\*
• Received an investigational drug within 28 days prior to Visit 1 that in the opinion of the investigator may affect the applicant's ability to participate in the study or the study results \*Self-reported, no clinical testing will be performed

Sponsors & Collaborators

• Commonwealth Scientific and Industrial Research Organisation, Australia: lead
• v2food (https://www.v2food.com/): collaborator

Study Officials

• Bev Muhlhausler, BSc(Hons) PhD

  Commonwealth Scientific and Industrial Research Organisation, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke S Wymond, BNutrDiet(Hons)

CONTACT

+61 8 8303 8856; brooke.wymond@csiro.au

Bev Muhlhausler, BSc(Hons) PhD

CONTACT

+61 8 8303 0697; Bev.Muhlhausler@csiro.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participants are blinded). The provision of the two test meals will be randomised and participants will be blinded to which meal they will receive (although we acknowledge they may be able to distinguish them by taste).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Technician

Model Details: Single-centre, single-blinded, randomised, cross-over trial.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 6, 2021
• Study Start: August 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share