NCT07361406

Brief Summary

The aim of the study is to investigate the effect of non-nutritive sweeteners on glucose regulation. Secondary objectives are to investigate the effect of NNS on gut microbiome, gut hormone secretion, sweet taste sensitivity and preference, and the excretion of NNS in urine.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

January 13, 2026

Last Update Submit

February 24, 2026

Conditions

Healthy Adult

Keywords

glucose metabolismgut microbiomegut hormonesnon-nutritive sweeteners

Outcome Measures

Primary Outcomes (1)

  • Difference in change in 2h iAUC glucose after 6 weeks between the intervention and the control.

    The primary outcome measure is the difference in change in iAUC of blood glucose levels following a 2-hour oral glucose tolerance test (OGTT) after six weeks between the intervention period and the control period.

    Week 2 and week 8 in both intervention periods (4 times in total)

Secondary Outcomes (19)

  • Matsuda index

    Week 2 and week 8 in both intervention periods (4 times in total)

  • Fasting blood glucose

    Baseline & 2 times per intervention period (week 2 and week 8). 5 times in total.

  • Fasting blood insulin

    Baseline & 2 times per intervention period (week 2 and week 8). 5 times in total.

  • Postprandial insulin response

    Week 2 and 8 in both intervention periods (4 times in total).

  • Postprandial glucose response after a breakfast

    Week 7 in both study periods (2 times in total)

  • +14 more secondary outcomes

Other Outcomes (9)

  • Anthropometrics

    Baseline

  • Body composition

    Baseline & week 8 of both intervention periods (3 times in total).

  • Habitual food intake

    Baseline

  • +6 more other outcomes

Study Arms (2)

NNS / no-NNS

OTHER

In this arm, participants will first receive the NNS diet, and the no-NNS diet in the second study period.

Other: Diet with non-nutritive sweetenersOther: Diet without non-nutritive sweeteners

No-NNS / NNS

OTHER

In this arm, participants will first receive the no-NNS diet, and the NNS diet in the second study period.

Other: Diet with non-nutritive sweetenersOther: Diet without non-nutritive sweeteners

Interventions

Diet with non-nutritive sweetenersOTHER

Fully controlled diet with added mixture of non-nutritive sweeteners. The mixture consist of 6 different non-nutritive sweeteners: acesulfame-K, aspartame, cyclamate, saccharin, sucralose, and rebaudioside A (stevia).

NNS / no-NNSNo-NNS / NNS
Diet without non-nutritive sweetenersOTHER

Fully controlled diet without any non-nutritive sweeteners added.

NNS / no-NNSNo-NNS / NNS

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-79 years;
  • BMI of 20-35 kg/m2;
  • Having veins suitable for placement of a venflon catheter.

You may not qualify if:

  • Diseases or prior surgeries affecting the stomach, liver, kidneys or intestines (allowed i.e. appendectomy);
  • Cardiovascular diseases (e.g. heart failure) or cancer (e.g. non-invasive skin cancer allowed);
  • Diagnosed with type 1 or type 2 diabetes;
  • HbA1c level \>6.5% (\>48 mmol/mol), as measured during the screening visit;
  • Anaemia defined as Hb concentrations \<8.5 mmol/L for men and \<7.5 mmol/L for women via finger prick;
  • Regular use of/receiving medication interfering with research outcomes (as judged by research physician), such as use of glucose lowering drugs, insulin, or use of medication that impacts the gastro-intestinal system;
  • Use of antibiotics over the last 3 months before study start;
  • Donated blood within 2 months prior to the screening;
  • Food allergies, intolerances (including lactose/gluten intolerance) for products used in the study design and/or dietary restrictions interfering with the study (including special diets and eating disorders);
  • Followed a diet that can interfere with the study outcomes within 1 month prior to the screening (e.g. ketogenic, sugar free, carbohydrate free);
  • Not willing to eat all products in the study diet, including eggs and dairy. Vegetarian is possible;
  • Not willing to consume non-nutritive sweeteners;
  • Not willing to quit the use of supplements that can interfere with the study outcomes (e.g. pre- or probiotics).
  • Intention to change the intensity of exercise during the study period or planning to join a intensive sport event (e.g. marathon or triathlon);
  • Intention to lose or gain weight;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708WG, Netherlands

RECRUITING

MeSH Terms

Interventions

DietNon-Nutritive Sweeteners

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 23, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

November 26, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

NL(1)