Mapping the 'Sweet Brain' in Healthy Participants

NCT04162457 | Completed

• 1 other identifier: 6814
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The human brain has a central role in regulating appetite and food intake. It integrates many metabolic, hedonic and trait-related signals that affect eating behaviour and determine when and how much we eat. The effects of non-nutritive sweeteners (NNS) that provide sweet taste with no calories on appetite, food intake thus weight status remain a subject of debate. In this study, the investigators aim to investigate whole brain response to the ingestion of beverages sweetened with caloric sugars (glucose, maltodextrin) or NNS (stevia) as well as neural substrates of attentional bias to food (pre-and post consumption) in healthy lean participants.

Conditions

Obesity; Sweeteners

Outcome Measures

Primary Outcomes (2)

• physMRI whole brain responses to stevia, glucose and maltodextrin

  Participants will undergo a physiological MRI, which will include 10 minutes of baseline (resting), 10 minutes of drinking the solution, and 20 minutes post-consumption (resting).

  -10 minutes to 30 minutes post consumption

• fMRI brain response while performing a food visual dot probe task (VPT)

  Before and 30 minutes after the consumption of the study beverage, participants will perform a food VPT which is designed to assess attentional bias to food cues while an fMRI will be conducted. Subjects neural activation when they are responding to congruent trials (dot appearing on the position of a food picture) compared to incongruent trials (dot appearing on the position of a neutral picture).

  10 minutes (twice)

Secondary Outcomes (3)

• Attentional bias to food cues (behavioral)

  pre- and post (30 minutes) consumption of the study beverage

• Appetite ratings

  -10 minutes (before consumption) to 30 minutes post-consumption

• Sweetness ratings

  at 10 minutes postprandially

Study Arms (4)

Stevia beverage

EXPERIMENTAL

Participants receive 4 study beverages in the 4 imaging sessions in randomised and counterbalanced order.

Dietary Supplement: Stevia

Glucose beverage

EXPERIMENTAL

330 ml of water with glucose (equal sweetness with the stevia beverage)

Dietary Supplement: Glucose

Maltodextrin beverage

EXPERIMENTAL

330 ml of water with maltodextrin (equal amount of calories as the glucose beverage)

Dietary Supplement: Maltodextrin

Water

PLACEBO COMPARATOR

330 ml water

Dietary Supplement: Water

Interventions

Stevia DIETARY_SUPPLEMENT

Participants will be administered one of the study beverages at each one of the 4 imaging sessions.

Stevia beverage

Glucose DIETARY_SUPPLEMENT

Participants will be administered one of the study beverages at each one of the 4 imaging sessions.

Glucose beverage

Maltodextrin DIETARY_SUPPLEMENT

Participants will be administered one of the study beverages at each one of the 4 imaging sessions.

Maltodextrin beverage

Water DIETARY_SUPPLEMENT

Participants will be administered one of the study beverages at each one of the 4 imaging sessions.

Water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 40 years
• BMI between 18.5-25 kg/m2
• Registered to a GP
• Non-restrained eaters, restraint eating score on the Dutch Eating Behaviour Questionnaire (DEBQ) ≤ 3
• Healthy - general good health
• Currently not taking any medication (other than females taking the oral contraceptives or over the counter medication such as paracetamol)
• Normal or corrected vision
• Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
• Regular breakfast eaters (≥5 times per week)
• Stable weight, ± 5 kg last 3 months
• No self-reported food allergy or intolerance to foods supplied during the study
• No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
• Willing to comply with the study protocol
• Willingness to be informed about chance findings of pathology
• The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• Habitual NNS consumers, \>1 can of diet beverage or \>1 table packet of sweeteners per week
• Subjects who have a non-removable metal object in or at their body, such as, for example: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
• Tattoos, that are older than 15 years
• Claustrophobia
• Pathological hearing ability or an increased sensitivity to loud noises
• Operation less than 3 months ago
• Acute illness or infection during the last 4 weeks
• Moderate or severe head injury
• Any metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression), gastrointestinal or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
• Currently experiencing anxiety or depression
• Use of recreational substances in the last month
• Age under 18 years or over 40 years old.
• BMI \>25 kg/m2 and \<18.5 kg/m2
• Restrained eaters (DEBQ for restraint eating ≥ 3)
• Current weight loss regimens, or more than 5 kg weight loss/gain in the last 3 months

Sponsors & Collaborators

• University of Manchester: lead
• Cargill: collaborator

Study Sites (1)

University of Manchester

Manchester, M13 9PG, United Kingdom

Location

Related Publications (2)

• Stamataki NS, Elliott R, McKie S, McLaughlin JT. Attentional bias to food varies as a function of metabolic state independent of weight status. Appetite. 2019 Dec 1;143:104388. doi: 10.1016/j.appet.2019.104388. Epub 2019 Jul 31.

  PMID: 31376438 BACKGROUND

• Little TJ, McKie S, Jones RB, D'Amato M, Smith C, Kiss O, Thompson DG, McLaughlin JT. Mapping glucose-mediated gut-to-brain signalling pathways in humans. Neuroimage. 2014 Aug 1;96:1-11. doi: 10.1016/j.neuroimage.2014.03.059. Epub 2014 Mar 28.

  PMID: 24685436 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

stevioside; Glucose; maltodextrin; Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double blind. All participants are completing 4 testing sessions in randomised and counterbalanced order. Participants and researchers (who are also outcome assessors) are blinded to the beverages content. Un-blinding will be performed following analysis of results
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: Counter-balanced, double-blind, crossover, within-subject design.

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: November 14, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after the results of the study will get accepted for publication by an international peer-reviewed journal, provided participants consent.
• Access Criteria: All researchers

Locations

GB (1)