Brain and Glycemic Responses to Sweet Soft Drinks

NCT ID: NCT05575687

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-03-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Normal Physiological Response to Sweet Drinks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Water

Ingestion of 500 ml of mineral water

Group Type OTHER

Water (reference)

Intervention Type OTHER

Ingestion of 500 ml mineral water

Sucrose

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

Group Type OTHER

Sucrose

Intervention Type OTHER

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

Sucralose

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

Group Type OTHER

Sucralose

Intervention Type OTHER

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

Stevia

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

Group Type OTHER

Stevia

Intervention Type OTHER

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

Monk fruit

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

Group Type OTHER

Monk fruit

Intervention Type OTHER

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

Allulose + stevia

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

Group Type OTHER

Allulose + stevia

Intervention Type OTHER

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

Interventions

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Water (reference)

Ingestion of 500 ml mineral water

Intervention Type OTHER

Sucrose

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

Intervention Type OTHER

Sucralose

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

Intervention Type OTHER

Stevia

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

Intervention Type OTHER

Monk fruit

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

Intervention Type OTHER

Allulose + stevia

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tate & Lyle

INDUSTRY

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Paul Smeets

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Smeets, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Human Research Unit - Division of Human Nutrition and Health

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL81742.091.22

Identifier Type: -

Identifier Source: org_study_id

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