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

Summary

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).

Conditions

• Obesity

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

• Harokopio University

  collaborator OTHER

• University of Navarra

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Wageningen University

  collaborator OTHER

• European Clinical Research Infrastructure Network

  collaborator OTHER

• University of Surrey

  collaborator OTHER

• Bioiatriki Idiotiko Polyiatreio Iatpikh Anonymos Etairia

  collaborator UNKNOWN

• NetUnion SARL

  collaborator UNKNOWN

• Pectolite GMBH

  collaborator UNKNOWN

• Anne Birgitte Raben

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-30

Primary Completion

2022-10-06

Completion

2022-10-06

Countries

• Denmark
• Greece
• Netherlands
• Spain

Study Locations