Low Calorie Sweeteners Effects on Appetite

NCT07018921 | Completed

• 1 other identifier: 2022-15284-25905
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The principal research question is whether the ingestion of stevia (rebaudioside A) in encapsulated format will have any effects on blood glucose, appetite and food intake in healthy human volunteers.

Conditions

Appetite

Outcome Measures

Primary Outcomes (1)

• Energy intake

  Participants are allowed to eat from a buffet lunch until they feel comfortably full.

  Lunch at 30 min after the ingestion of the treatment

Secondary Outcomes (2)

• Appetite ratings

  0, 15, 30 and 60 min

• Blood glucose

  0, 15, 30 and 60 min

Other Outcomes (1)

• Meal attributes in VAS scales

  60 min

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design.

Dietary Supplement: rebaudioside A; Dietary Supplement: Placebo

rebaudioside A

ACTIVE COMPARATOR

Participants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design.

Dietary Supplement: rebaudioside A; Dietary Supplement: Placebo

Interventions

rebaudioside A DIETARY_SUPPLEMENT

rebaudioside A encapsulated in a vegetarian capsule

Placebo; rebaudioside A

Placebo DIETARY_SUPPLEMENT

carboxymethylcellulose encapsulated in a vegetarian capsule

Placebo; rebaudioside A

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 18.5-24.9 kg/m2
• DEBQ for restraint eating ≤ 3
• Healthy - general good health
• Currently not taking any medication (other than females taking the oral contraceptives, or medication that does not affect taste, and glucose response)
• 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
• The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• The participant is able to read, comprehend and record information written in English.
• A signed and dated written informed consent is obtained from the participant.

You may not qualify if:

• Age under 18 years or over 40 years old.
• BMI ≥25 kg/m2 and \<18.5kg/m2
• Subjects who are currently on a diet
• Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Raw Food Diet etc.
• Vegetarians, vegans
• Subjects having breakfast fewer than 5 times per week.
• Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
• Subjects with eating disorders (binge eating disorder, bulimia etc)
• Subjects who are currently experiencing anxiety or depression.
• Participants who drink more than the NHS guidelines (14 units per week)
• Participants who are, or may be, pregnant, or currently lactating.
• Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
• Subjects who have aversions to foods related with the study.
• Subjects with food allergies or intolerance related with the foods/ drinks of the study.
• Habitual NNS consumers, \>1 can of diet beverage or \>1 sachet of low calorie sweeteners (corresponding to 1 spoonful) per week.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Interventions

rebaudioside A

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Nikoleta Stamataki

Model Details: This study is double blind. All participants are completing 2 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: June 13, 2025
• Study Start: March 15, 2023
• Primary Completion: May 19, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2025

Record last verified: 2023-03

Locations

GB (1)