Health TrialsbyHealthPanel

SweetSpot - The Effect of Non-nutritive Sweeteners on Health

ConditionHealthy Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-79
SponsorWageningen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 45-79 years;

BMI of 20-35 kg/m2;

Having veins suitable for placement of a venflon catheter.

Disqualifiers

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;

Drug treated thyroid diseases (well substituted hypothyroidism is allowed for inclusion);

Trial design

Design model

Crossover

Treatments tested in this trial

  • Diet with non-nutritive sweeteners

    Other intervention

    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).

  • Diet without non-nutritive sweeteners

    Other intervention

    Fully controlled diet without any non-nutritive sweeteners added.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: NNS / no-NNSOther 2 interventions
Group B: No-NNS / NNSOther 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Matsuda index

Matsuda index after an OGTT

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

Fasting blood glucose

Fasting blood glucose

Time frame
Baseline & 2 times per intervention period (week 2 and week 8). 5 times in total.
3

Fasting blood insulin

Fasting blood insulin

Time frame
Baseline & 2 times per intervention period (week 2 and week 8). 5 times in total.
4

Postprandial insulin response

2-hour iAUC blood insulin during OGTT

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

Other outcomes

1

Anthropometrics

Measured as weight (kg), height (m), waist circumference (cm), and hip circumference (cm). Weight and height will be combined to report BMI in kg/m\^2.

Time frame
Baseline
2

Body composition

Body composition as measured by DEXA (Dual Energy X-ray Absorptiometry).

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

Habitual food intake

Habitual dietary intake assessment with a food frequency questionnaire (FFQ).

Time frame
Baseline
4

Physical activity level

Physical activity level by the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH).

Time frame
Baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wageningen University

Lead sponsor

Food & Biobased Research - Wageningen UR

Collaborator

TKI Agri & Food

Collaborator

The Magnum Ice Cream Company

Collaborator

Tate & Lyle

Collaborator

Symrise AG

Collaborator

American Beverage Association

Collaborator

Yildiz Holding

Collaborator

Source ClinicalTrials.gov
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