Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2022-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption of sweetener and sweetness enhancers (S\&SEs) within a healthy diet approach will improve weight loss maintenance and obesity related risk factors, and affect safety markers, compared to sugar.

We hypothesize, that:

* Prolonged use of S\&SEs in beverages and food matrices will result in improved body weight control because S\&SEs will increase palatability of the diet and thereby increase compliance to the recommendations for a healthy diet.
* There will be no safety concerns using S\&SEs in the long term.

Overweight/obese adults and families where at least one adult (both gender) and one child (both gender) are overweight/obese will be recruited. The majority of measurements will only be conducted in the adult population and some measurement will only be done in sub-groups. The intervention will be performed in four countries: Denmark, Greece, Spain and the Netherlands.

The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children (6-12 years of age) - will be recruited for the study. All adult participants are first treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum 5% weight loss (WL)), whereas children are treated separately with a conventional weight maintenance (WM) diet, without a specific aim for absolute WL.

The participants - both adults and families - are randomized into two different diet interventions for 10 months with or without inclusion of S\&SEs products (foods and drinks). For adults, this period aims at preventing weight re-gain and for children maintaining body mass index (BMI)-for-age. The participants will receive food exchange lists and will be guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not participating with children) belonging to the same household and all members of a family will be assigned the same intervention - the randomization will here solely be based on the oldest adult in the family/household.

The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5, and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but less strict time schedule (their participation is preferred but not required for all dietician meetings).

The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline, start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6 months from baseline) and 12 (1 year from baseline).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Sweeteners on Behaviour, Physiology & Health

NCT04633681

Eating Behavior

COMPLETED NA

The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults

NCT02335021

Impairment of Oral Perception Insulin Resistance

COMPLETED NA

On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota

NCT02580110

Healthy Subjects

COMPLETED NA

The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents

NCT02499705

Insulin Resistance Obesity

TERMINATED NA

Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

NCT02890108

Insulin Sensitivity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sweeteners and sweetness enhancers (S&SEs)

Healthy diet \< 10 energy % (E%) sugar, foods and drinks with S\&SEs allowed.

Group Type EXPERIMENTAL

S&SEs

Intervention Type BEHAVIORAL

S\&SEs:

As many sugar-containing products in the diet as possible should be replaced with S\&SE-containing products.

To ensure that a certain amount of S\&SE products is consumed every day, a fixed minimum amount of units for each individual is planned.

Sugar group

Healthy diet, \< 10 E% sugar, foods and drinks with S\&SEs not allowed.

Group Type ACTIVE_COMPARATOR

Sugar

Intervention Type BEHAVIORAL

Sugar group:

In the sugar group it is allowed to consume up to a certain number of units of sugar-containing products each day, corresponding to \< 10 E% added sugar.

The sugar group is not allowed to consume any S\&SE products.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S&SEs

S\&SEs:

As many sugar-containing products in the diet as possible should be replaced with S\&SE-containing products.

To ensure that a certain amount of S\&SE products is consumed every day, a fixed minimum amount of units for each individual is planned.

Intervention Type BEHAVIORAL

Sugar

Sugar group:

In the sugar group it is allowed to consume up to a certain number of units of sugar-containing products each day, corresponding to \< 10 E% added sugar.

The sugar group is not allowed to consume any S\&SE products.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18-65 years.
* BMI: ≥25.0 kg/m2 (no upper limit). For women: Use of contraceptive methods and not wishing/planning to become pregnant in the 1 year of the intervention study.
* Regular consumption of sugar-containing/sugar-sweetened products.
* Able to participate in CIDs and dietician meetings during normal working hours.
* Motivation and willingness to be randomized to any of the two groups and to do the best to follow the given protocol.

* Age: 6-12 years.
* BMI-for-age: \>85th percentile (no upper limit).
* Able to participate in CIDs during normal working hours.
* Motivation and willingness to be randomized to any of the two groups and to do the best to follow the given protocol.

Exclusion Criteria

* Weight change (increase or decrease) \>5% during the past 2 months prior to the study.
* Surgical treatment of obesity.
* Blood donation \< 3 month prior to study.
* Change in smoking habits during the last month. Smoking is allowed provided subjects have not recently changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
* Regularly drinking \>21 alcoholic units per week (men), or \>14 alcoholic units/week (women).
* Intensive physical training (\>10 hours of per week).
* Self-reported eating disorders.
* Intolerance and allergies expected to interfere with the study.
* Self-reported drug abuse within the previous 12 months.
* Night- or shift work that ends later than 11 PM.
* For women: Pregnancy, lactation.
* Persons who do not have access to either (mobile) phone or internet (this is necessary when being contacted by the study personnel during the study).
* Insufficient communication with national language.
* Inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible
* Participant's general condition contraindicates continuing the study as evaluated by the daily study manager, site-PI, PI or clinical responsible.
* Simultaneous participation in other clinical intervention studies.

Medical conditions as known by the persons:

* Diagnosed diabetes mellitus.
* Medical history of CVD (e.g. current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease).
* Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg (measured at screening) whether on or off treatment for hypertension.
* Significant liver disease, e.g. cirrhosis (fatty liver disease allowed).
* Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed).
* Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption.
* Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism if the person has been on a stable dose for at least 3 months.
* Psychiatric illness (e.g. major depression, bipolar disorders).

Medication:

* Use currently or within the previous 3 months of prescription or over the counter medication that has the potential of affecting body weight incl. food supplements. Except: low dose antidepressants if they, in the judgement of the daily study manager, site-PI, PI or clinical responsible, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the person has been on a stable dose for at least 3 months.
* Cholesterol or blood pressure lowering medication, if the dose has changed during the last 3 months (i.e. the medication is allowed if the participant has been on a stable dose for at least 3 months).

Laboratory screening:

If all of the above criteria are satisfied, the adult participant is eligible for a laboratory screening. A blood sample is collected and immediately analysed for glucose and haemoglobin concentrations (Haemocue).

* Glucose ≥ 7.0 mmol/L.
* Haemoglobin concentration below local laboratory reference values (i.e. anaemia).
* Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment.

After WL period (CID2, Month 2):

Failure to reach at least 5% weight reduction during the WL period (Months 0-2). This leads to exclusion from the WM intervention

* Intensive physical training (\>10 hours of per week).
* Self-reported eating disorders.
* Intolerance and allergies expected to interfere with the study.
* Insufficient communication with national language.
* Inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible.
* Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible.
* Simultaneous participation in other clinical intervention studies.

Medical conditions as known by the child and the representative adult:

* Diagnosed diabetes mellitus.
* Other diseases that may influence the study outcomes as evaluated by the daily study manager, site-PI, PI or clinical responsible.

Medication:

* Use currently or within the previous 3 months of prescription or over the counter medication that has the potential of affecting body weight.

Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes