Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Energy Intake at a test meal
研究概览
简要总结
The purpose of this randomised control trial is to determine whether consuming PulseOn enriched crackers for breakfast influences post-prandial glycaemic response and markers of appetite (hunger, fullness, desire to eat) over 4 hours, and energy intake at an ad libitum lunch meal on the same day. Healthy individuals with no underlying metabolic disease will be recruited to take part in this study.
详细描述
PulseON® is a unique flour that is made 100% from pulses, but unlike other flours it has been obtained through an alternative milling process (WO2019155190) which preserves whole plant cells (Edwards et al., 2020). These cells were shown to remain intact during down-stream processing into food products including bread and biscuits, and influence glycaemic response to these foods (Delamare et al., 2020; Bajka et al., 2021). Interestingly, the PulseON®-enriched breads also significantly enhanced and prolonged release of the gut hormones glucagon-like peptide-1 (GLP1) and peptide YY (PYY), which are known to have anorexigenic effects (Bajka et al., 2023). Studies using chick pea purees and hummus products have also shown positive findings in relation to appetite sensations and food intake (Pälchen et al., 2022; Alshaalan et al., 2024).
This work aims to recruit 50 participants through the use of posters and emails at Sheffield Hallam University, as well as in the local Sheffield area and through social media.
-30 minutes - baseline measures (body mass index (kg/m2), waist circumference (cm), blood glucose (mmol/l), hunger, fullness, desire to eat) are taken
0 minutes - pre-load consumed within 15 minutes (75g wheat flour / PulseOn crackers) The wheat flour cracker is made from 100% wheat flour. The PulseOn cracker is made from 40% PulseOn flour and 60% wheat flour.
30, 45, 60, 75, 90, 105, 120, 150, 180, 210 minutes - repeat baseline measures
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)
盲法说明
Participants will not be told which arm of the trial they are taking part in. PulseOn crackers and the wheat flour control crackers have been matched as closely as possible for energy content and sensory characteristics. Participants will be asked to rate the acceptability of the crackers to determine whether there are any discernible differences, however they are required to consume a set amount.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over the age of 18y
排除标准
- •smoker / recreational drug user
- •restrained eater (as determined by the three factor eating questionnaire (TFEQ-R18))
- •pregnant / lactating
- •blood clotting disorder
- •taking medication for heart / metabolic disease
- •pacemaker fitted
- •energy restricted diet or lost >5% body weight in the last 3 months
- •elite athletes
- •dysphagia
- •food allergy / intolerance
- •disease / inflammation of the GI tract
结局指标
主要结局
Energy Intake at a test meal
时间窗: Participants consume the preload at 0 minutes, and the test meal at 240mins.
Following the consumption of either the control / PulseOn enriched preload (crackers), participants will be asked to consume a standardised lunch meal of pasta and tomato sauce until they are full. The amount consumed will be measured using the Sussex Ingestion Pattern Monitor, and reported in grams and kcals.
Glycaemic response
时间窗: Baseline blood measures to be taken at -30 minutes. Participants consume the preload at 0 minutes, and capillary blood samples are measured at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.
Following the consumption of either the control / PulseOn enriched preload (crackers), capillary blood samples will be measured at 15 / 30 minute intervals up to lunch time.
Markers of appetite
时间窗: Baseline hunger, fullness and desire to eat to be taken at -30 minutes. Participants consume the preload at 0 minutes, and further hunger, fullness and desire to eat measures are taken at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.
Following the consumption of either the control / PulseOn enriched preload (crackers), hunger, fullness and desire to eat will be measured at 15 / 30 minute intervals up to lunch time using visual analogue scale.
次要结局
- Post intervention food / energy / nutrient intake(24hrs post intervention)
- Mood(Baseline mood ratings will be measured at -30 minutes. Participants consume the preload at 0 minutes, and further mood ratings are measured at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.)
研究者
Anna Sorsby
Senior Lecturer in Nutrition
Sheffield Hallam University