Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity – the SWEET Project

Introduction
Intake of free sugars in European countries is high and attempts to reduce sugar intake have been mostly ineffective. Non-nutritive sweeteners and sweetness enhancers (S&SEs) can maintain sweet taste in the absence of energy, but little is known about the impact of acute and repeated consumption of S&SE in foods on appetite. This study aims to evaluate the effect of acute and repeated consumption of two individual S&SEs and two S&SE blends in semisolid and solid foods on appetite and related behavioural, metabolic and health outcomes.

Methods and analysis
A work package of the SWEET Project; this study consists of five double-blind randomised cross-over trials which will be carried out at five sites across four European countries, aiming to have n=213. Five food matrices will be tested across three formulations (sucrose-sweetened control vs two reformulated products with S&SE blends and no added sugar). Participants (body mass index 25–35 kg/m2; aged 18–60 years) will consume each formulation for 14 days. The primary endpoint is composite appetite score (hunger, inverse of fullness, desire to eat and prospective food consumption) over a 3-hour postprandial incremental area under the curve during clinical investigation days on days 1 and 14.

Ethics and dissemination
The trial has been approved by national ethical committees and will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed open-access scientific journals. Research data from the trial will be deposited in an open-access online research data archive.

Trial registration number
NCT04633681.

Leggi
Dicembre 2022

Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults: a protocol of the StayFine RCT

Introduction
Youth in remission of depression or anxiety have high risks of relapse. Relapse prevention interventions may prevent chronicity. Aim of the study is therefore to (1) examine efficacy of the personalised StayFine app for remitted youth and (2) identify high-risk groups for relapse and resilience.

Method and analysis
In this Dutch single-blind parallel-group randomised controlled trial, efficacy of app-based monitoring combined with guided app-based personalised StayFine intervention modules is assessed compared with monitoring only. In both conditions, care as usual is allowed. StayFine modules plus monitoring is hypothesised to be superior to monitoring only in preventing relapse over 36 months. Participants (N=254) are 13–21 years and in remission of depression or anxiety for >2 months. Randomisation (1:1) is stratified by previous treatment (no treatment vs treatment) and previous episodes (1, 2 or >3 episodes). Assessments include diagnostic interviews, online questionnaires and monitoring (ecological momentary assessment with optional wearable) after 0, 4, 12, 24 and 36 months. The StayFine modules are guided by certified experts by experience and based on preventive cognitive therapy and ingredients of cognitive behavioural therapy. Personalisation is based on shared decision-making informed by baseline assessments and individual symptom networks. Time to relapse (primary outcome) is assessed by the Kiddie Schedule for Affective Disorders and Schizophrenia-lifetime version diagnostic interview. Intention-to-treat survival analyses will be used to examine the data. Secondary outcomes are symptoms of depression and anxiety, number and duration of relapses, global functioning, and quality of life. Mediators and moderators will be explored. Exploratory endpoints are monitoring and wearable outcomes.

Ethics, funding and dissemination
The study was approved by METC Utrecht and is funded by the Netherlands Organisation for Health Research and Development (636310007). Results will be submitted to peer-reviewed scientific journals and presented at (inter)national conferences.

Trial registration number
NCT05551468; NL8237.

Leggi
Dicembre 2022