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

Healthy Participants Clinical Trial

Official title:

Defining the Satiety Characteristics of Plant-based Mince in Comparison to Standard Beef Mince: Does Plant-based Mince Make You Feel Fuller for Longer?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04950595
• Other study ID #: VTF001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2021
• Est. completion date: October 2021

Study information

• Verified date: June 2021
• Source: Commonwealth Scientific and Industrial Research Organisation, Australia
• Contact: Brooke S Wymond, BNutrDiet(Hons)
• Phone: +61 8 8303 8856
• Email: brooke.wymond[@]csiro.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Growing concerns about the sustainability and environmental impacts of red meat consumption have resulted in the increased uptake of plant-based red meat substitutes by consumers worldwide. In addition to the environmental benefits of these products, it has also been argued that they have the potential to offer additional health benefits. One such health benefit, and the focus of this study, is the potential for plant-based meats to produce a greater satiating effect in comparison to traditional meat products, and therefore potentially assist in supporting weight loss or weight maintenance in the longer term.

To address this question, the investigators will assess the effect of substituting V2 mince for beef mince in a standard pasta meal on both the amount of the meal consumed and on feelings of fullness in the period after eating, as assessed by both subjective reporting, objective (biochemical) measures and the amount consumed at a subsequent meal occasion. The results of this study will provide proof-of-concept evidence of the potential enhanced satiating effects of V2 mince, and therefore whether it could potentially assist in a weight reduction dietary regime when substituted for standard beef mince.

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.

The investigators specific hypotheses are:

H1: That participants will consume less KJ when consuming the V2 plant-based meal in comparison to the equivalent meal prepared with beef mince.

H2: That fullness will be maintained to the same extent following consumption of the V2 and meat-based meals, such that participants will not increase their consumption at the subsequent meal period to compensate for this energy deficit.

The null hypothesis is that a meal containing V2 plant-based meat is no more satiating than an equivalent meal containing beef mince.

This study is a single-blinded, randomised cross-over trial, designed to compare the effect of a meal prepared using V2 plant-based meat to an equivalent meal prepared with beef mince on the amount consumed in the current meal and objective and subjective measures of post-prandial satiety. The test meals will be formulated so that the meal will contain 45% of V2 plant-based meat or beef mince prior to the meal being cooked. Participants will be provided with a serving that is expected to be in excess of what they would be able to comfortably eat, and instructed to eat until comfortably full. The amount of the leftovers will be carefully weighed and used to calculate the volume, energy and macronutrient intake consumed.

180 mins after lunch (~3 pm), subjects will be presented with a standard cold buffet meal (including sliced bread, chicken, ham, cheese, mayonnaise, custard, yogurt, fruit salad and water) in excess of what they are expected to consume and allowed to eat ad libitum for up to 30 minutes. Participants will be asked to eat until they are comfortably full. The amount of each item consumed will be weighed and used to calculate total volume, energy and macronutrient intake.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 56 Years

Eligibility

Inclusion Criteria:

1. Male individuals

2. Aged between =18 & =56 years at informed consent

3. Body mass index (BMI) =18.5 kg/m² and =27.5 kg/m² (confirmed during screening appointment)

4. Weight stable for last 6 months (< +/- 5kg change)*

5. Consume red meat regularly (at least 1 x week)

6. Willing to provide written Informed Consent

7. Be able to attend the CSIRO nutrition clinic for around 7 hours on two occasions across a two week period.

• Self-reported

Exclusion Criteria:

1. 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

2. 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

3. Known food allergies or intolerances to the study intervention products^

4. History of eating disorders*

5. Unable or unwilling to consume red meat

6. Current smoker (or history of smoking within the last six months)

7. History of or known presence of alcohol abuse or illicit drug use*

8. 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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• Plant-based mince
Spaghetti bolognaise meal made with plant-based mince
• Beef mince
Spaghetti bolognaise meal made with beef mince

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Commonwealth Scientific and Industrial Research Organisation, Australia	v2food (https://www.v2food.com/)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Energy consumed at subsequent buffet meal (kJ)	measuring post-prandial satiety	4 hours
Secondary	Glucose (mmol/L) (plasma biomarker)	measuring post-prandial satiety	4 hours
Secondary	insulin (pmol) (plasma biomarker)	measuring post-prandial satiety	4 hours
Secondary	ghrelin (mcg) (plasma biomarker)	measuring post-prandial satiety	4 hours
Secondary	cholecystokinin (CCK) (plasma biomarker)	measuring post-prandial satiety	4 hours
Secondary	glucagon-like peptide-1 (GLP-1) (plasma biomarker)	measuring post-prandial satiety	4 hours