Brain and Glycemic Responses to Sweet Soft Drinks

NCT05575687 | Completed

• 1 other identifier: NL81742.091.22
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Normal Physiological Response to Sweet Drinks

Outcome Measures

Primary Outcomes (1)

• Local brain perfusion

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

  T=5 and T=30 minutes after the start of consumption

Secondary Outcomes (4)

• Seed-based functional connectivity

  T=5, T=30 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

• Gastric content volume

  Baseline, T=15, 25 and 45 minutes after the start of consumption

Other Outcomes (2)

• Subjective ratings

  T=15, 25, 30, 45 and 60 minutes after the start of consumption

• Beverage ratings

  T=0 minutes (after a few sips)

Study Arms (6)

Water

OTHER

Ingestion of 500 ml of mineral water

Other: Water (reference)

Sucrose

OTHER

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

Other: Sucrose

Sucralose

OTHER

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

Other: Sucralose

Stevia

OTHER

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

Other: Stevia

Monk fruit

OTHER

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

Other: Monk fruit

Allulose + stevia

OTHER

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

Other: Allulose + stevia

Interventions

Water (reference) OTHER

Ingestion of 500 ml mineral water

Water

Sucrose OTHER

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

Sucrose

Sucralose OTHER

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

Sucralose

Stevia OTHER

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

Stevia

Monk fruit OTHER

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

Monk fruit

Allulose + stevia OTHER

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

Allulose + stevia

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Tate & Lyle: collaborator

Study Sites (1)

Human Research Unit - Division of Human Nutrition and Health

Wageningen, 6708 WE, Netherlands

Location

MeSH Terms

Interventions

Water; Sucrose; trichlorosucrose; stevioside; psicose

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Paul Smeets, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 12, 2022
• Study Start: January 9, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)