跳至主要内容
临床试验/NCT05575687
NCT05575687已完成不适用

Brain and Glycemic Responses to Soft Drinks With Different Sweeteners

Wageningen University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Local brain perfusion

研究概览

简要总结

The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years.

The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners.

Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).

详细描述

Rationale: The brain is crucial in the regulation of energy intake and maintaining homeostasis which is subserved by an interaction of homeostatic and reward-related brain areas. These brain areas integrate multiple neural and hormonal signals related to energy content such as sweet taste and food reward in the form of ingested energy. Sugar-sweetened soft drinks have been shown to contribute to overconsumption and obesity. Therefore, there is great consumer interest in drinks with low-caloric sweeteners because they do not contribute to energy intake while still providing the hedonic experience of sweet taste. However, different low-caloric sweeteners may have differential effects on the brain because of (subliminal) taste difference and their different metabolic fate. We hypothesize that the brain and glycemic responses to drinks sweetened with sugar and different low-caloric sweeteners will be different. This may have implications for their reward value.

Objective

To determine changes in brain activity in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners.

Study design: Randomized crossover design with six treatments. Study population: 30 healthy, non-smoking, normal-weight individuals, aged between 18 and 30 years.

Intervention: Participants will be scanned using MRI before and after consumption of six 500-ml drinks: water; water + sucrose; water + sucralose; water + stevia extract; water + allulose + stevia; water + monk fruit extract. Regional cerebral blood flow (rCBF) and resting state functional MRI (rsfMRI) scans will be made at baseline and at t=5 and t=30 min. Additionally, gastric emptying of the drinks will be examined through gastric MRI at t=15, 25 and 45 min. Blood samples will be collected to measure changes in insulin and glucose levels at baseline and at t=5, 15, 30, 45 and 60 min for all sweet treatments. Participants will rate their appetite and thirst at baseline and at t=15, 25, 30, 45 and 60 min.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

With the exception of the water treatment, treatment type will be blind for the participants and the researchers. The primary analysis will be performed completely blinded.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 18 and 30 years
  • •BMI between 18.5 and 25 kg/m2
  • •Apparently healthy (self-reported)
  • •Right-handed (because brain responses may differ between right- and left handed individuals)
  • •Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having antecubital veins suitable for blood sampling via a catheter
  • •Willing to comply with the study procedures
  • •Willing to be informed about incidental findings of pathology and consenting to informing their general practitioner about this.

排除标准

  • •Having disturbances of glucose metabolism such as being prediabetic or diabetic
  • •Use of medication that could influence study results including insulin/metformin/proton pump inhibitors, antacids, anti-depressants
  • •Allergy or intolerance for any of the study products/compounds (sucrose, sucralose, stevia extract, allulose, monk fruit extract)
  • •Being a regular smoker (smoking more than one cigarette or e-cigarette with nicotin per day)
  • •Drinking more than 14 glasses of alcohol a week
  • •Having genetic, psychiatric or neurological diseases affecting the brain
  • •Gastric disorders or regular gastric complaints (more than once per week), for example heart burn
  • •Having renal or hepatic disease
  • •Using recreational drugs more than once per week (e.g. marihuana, XTC, GHB, laughing gas)
  • •Having given a blood donation in the past two months
  • •Being pregnant, lactating or planning on becoming pregnant during the study
  • •Currently following or having followed calorie-restricted diet in the past two months
  • •Participating in other research during the study period
  • •Not having a general practitioner
  • •Being an employee or student of the Division of Human Nutrition and Health
  • •Having a contra-indication to MRI scanning

研究组 & 干预措施

Water

Other

Ingestion of 500 ml of mineral water

干预措施: Water (reference) (Other)

Stevia

Other

Ingestion of 500 ml of a flavored mineral water sweetened with stevia extract

干预措施: Stevia (Other)

Monk fruit

Other

Ingestion of 500 ml of a flavored mineral water sweetened with monk fruit extract

干预措施: Monk fruit (Other)

Allulose + stevia

Other

Ingestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract

干预措施: Allulose + stevia (Other)

Sucralose

Other

Ingestion of 500 ml of a flavored mineral water sweetened with sucralose

干预措施: Sucralose (Other)

Sucrose

Other

Ingestion of 500 ml of a flavored mineral water sweetened with sucrose

干预措施: Sucrose (Other)

结局指标

主要结局

Local brain perfusion

时间窗: T=5 and T=30 minutes after the start of consumption

Change from baseline rCBF in homeostatic and reward-related brain areas in a priori regions of interest (hypothalamus, ventral striatum, dopaminergic midbrain) over time

次要结局

  • Seed-based functional connectivity(T=5, T=30 minutes after the start of consumption)
  • Gastric content volume(Baseline, T=15, 25 and 45 minutes after the start of consumption)
  • Blood plasma glucose(T=5, 15, 30, 45 and 60 minutes after the start of consumption)
  • Blood plasma insulin(T=5, 15, 30, 45 and 60 minutes after the start of consumption)

研究者

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

Paul Smeets

Principal Investigator

Wageningen University

研究点 (1)

Loading locations...

相似试验