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临床试验/NCT04950595
NCT04950595Unknown2 期

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

Commonwealth Scientific and Industrial Research Organisation, Australia0 个研究点目标入组 28 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
28
主要终点
Energy (kJ) consumed in test meals

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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).

入排标准

年龄范围
18 Years 至 56 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Beef mince (Other)

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.

干预措施: Plant-based mince (Other)

结局指标

主要结局

Energy (kJ) consumed in test meals

时间窗: 3 hours

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.

Visual Analogue Scale (VAS)

时间窗: 4 hours

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.

次要结局

  • 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)
  • glucagon-like peptide-1 (GLP-1) (plasma biomarker)(4 hours)

研究者

发起方
Commonwealth Scientific and Industrial Research Organisation, Australia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bradley Klingner

Research Technician

Commonwealth Scientific and Industrial Research Organisation, Australia

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