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临床试验/NCT04876495
NCT04876495已完成不适用

Comparative Effects of Dairy and Plant-based Protein Intake on Acute Glucose Homeostasis and Appetite Regulation in Healthy Men

University of Westminster2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)

研究概览

简要总结

INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity).

Rice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.

详细描述

Intervention study with three treatment groups in a randomised, single-blind, triple crossover design.

Study population: Healthy male participants will receive three different isocaloric and -volumetric protein shakes prepared using whey, rice and potato protein powders on different trial days with at least a one-week washout period apart.

Biological samples (blood and saliva samples) are collected at various time points during the visit. Blood samples are collected at baseline 10 min prior (T-10), then at 30 min (T30), 60 min (T60), 120 min (T120) and at 180 min (T180) after protein shake consumption. Saliva samples are collected at baseline (T-10), then at every 30 minutes following protein shake consumption (T30, T60, T90, T120, T150, T180). In addition, pertinent questionnaires Visual Analogue Scale [VAS] for the assessment of satiety and VAS for the assessment of protein shakes' perception will be collected at T-10, T30, T60, T90, T120, T150, T180 and at T0, respectively

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males (18-65 years of age)
  • Healthy subjects

排除标准

  • <18 years or >65 years
  • Consumption of >21 units of alcohol/week
  • Any allergies/health issues related to items being ingested
  • Any serious illnesses or those on medication
  • Any illness affecting taste or appetite
  • Any gastrointestinal disorders
  • Any eating disorders
  • Any depression/mental disorders

结局指标

主要结局

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)

时间窗: Glucose measured 120 minutes post protein shake consumption

Marker: glucose (mmol/L)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)

时间窗: Insulin measured 180 minutes post protein shake consumption

Marker: insulin (ng/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)

时间窗: Glucose measured 30 minutes post protein shake consumption

Marker: glucose (mmol/L)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)

时间窗: Insulin measured 10 minutes prior to protein shake consumption

Marker: insulin (ng/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)

时间窗: Insulin measured 120 minutes post protein shake consumption

Marker: insulin (ng/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)

时间窗: Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption

Markers: peptide tyrosine tyrosine (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)

时间窗: Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption

Markers: peptide tyrosine tyrosine (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)

时间窗: Ghrelin (pg/mL) measured 60 minutes post protein shake consumption

Markers: ghrelin (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)

时间窗: Insulin measured 60 minutes post protein shake consumption

Marker: insulin (ng/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)

时间窗: Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption

Markers: glucagon-like peptide 1 (pM)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)

时间窗: Glucagon-like peptide 1 measured 30 minutes post protein shake consumption

Markers: glucagon-like peptide 1 (pM)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)

时间窗: Glucagon-like peptide 1 measured 120 minutes post protein shake consumption

Markers: glucagon-like peptide 1 (pM)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)

时间窗: Glucose measured 10 minutes prior to protein shake consumption

Marker: glucose (mmol/L)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)

时间窗: Glucose measured 60 minutes post protein shake consumption

Marker: glucose (mmol/L)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)

时间窗: Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption

Markers: peptide tyrosine tyrosine (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)

时间窗: Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption

Markers: peptide tyrosine tyrosine (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)

时间窗: Glucose measured 180 minutes post protein shake consumption

Marker: glucose (mmol/L)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)

时间窗: Insulin measured 30 minutes post protein shake consumption

Marker: insulin (ng/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)

时间窗: Glucagon-like peptide 1 measured 60 minutes post protein shake consumption

Markers: glucagon-like peptide 1 (pM)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)

时间窗: Glucagon-like peptide 1 measured 180 minutes post protein shake consumption

Markers: glucagon-like peptide 1 (pM)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)

时间窗: Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption

Markers: peptide tyrosine tyrosine (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)

时间窗: Ghrelin (pg/mL) measured 30 minutes post protein shake consumption

Markers: ghrelin (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)

时间窗: Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption

Markers: ghrelin (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)

时间窗: Ghrelin (pg/mL) measured 120 minutes post protein shake consumption

Markers: ghrelin (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)

时间窗: Ghrelin (pg/mL) measured 180 minutes post protein shake consumption

Markers: ghrelin (pg/mL)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120)

时间窗: Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption

Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite)

次要结局

  • To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®(VAS for Palatability collected immediately after protein shake consumption)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Gulrez Zariwala

Professor of Translational Physiology

University of Westminster

研究点 (2)

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