1. No category

Evidence Live, 13-14 April 2015, University of Oxford
Poster #37
SUGARED SODA VERSUS ZERO SODA
A demo RCT for the general public visiting a health fair
Laure Vallotton1, Pedro Marques-Vidal2, Grégoire Wuerzner1, Ali Maghraoui1,3, Carine Bardinet3, Bernard Waeber1, Bernard Burnand4, Thierry Buclin3
1Clinical Trial Unit, Lausanne University Hospital, 2Department of Medicine, Internal Medicine, Lausanne University Hospital,
3Division of Clinical Pharmacology, Lausanne University Hospital, 4Institute of Social and Preventive Medicine, Lausanne University Hospital / Switzerland
INTRODUCTION
•
•
•
Knowledge about RCTs deserves to be increased amongst the general public
Visitors of “Salon Planète Santé”, a health fair organized in Switzerland, were
invited to participate in a small double blind, randomized, controlled study
Our demo RCT was designed to address the following question:
“Should visitors like us expect a subjective difference
between a sugared soft-drink and its artificially sweetened version,
in terms of effect on thirst, hunger, energy and concentration?”
METHODS
Salon Planète Santé
Nov 13th to 16th 2014
Lausanne, Switzerland
Participants flow
311 randomised to
sugared soda
R
150ml
Sprite®
(“sugared”)
1:1 allocation ratio
150ml
Sprite Zero®
(“sweetened”)
Intervention
double-blind
30 min to 2h later…
Feedback
questionnaire
- intercurrent food/drink
- hunger, thirst,
concentration, energy *
- identification of soda
- willingness to get
randomised *
* 5-point Likert scale
270 returned
questionnaire &
were included in
analysis
Publication of results
www.chuv.ch/soda
277 returned
questionnaire &
were included in
analysis
Similar baseline data between groups
n females (%)
Median age, y
(range)
Median body height, cm
(range)
Median body weight, kg
(range)
Median BMI, kg/m2
(range)
Sugared soda
(n=270)
166 (66.4%)
48
(7-85)
168
(125-198)
65
(22-114)
23.4
(12.9-41.0)
Sweetened soda
(n=277)
173 (69.5%)
45
(8-85)
167
(115-197)
64
(29-140)
22.7
(14.2-45.7)
Participants drink / food habits
• 59% reported use of sugared sodas
• 44% reported use of sweetened sodas
• No correlation between BMI and reported
use of sugared or sweetened soda
Identification of soda by participants
• Most participants believed having
received the sweetened soda:
Statistical analysis
descriptive analyses
ordered logistic regression
320 randomised to
sweetened soda
84 did not return
questionnaire
Baseline
questionnaire
Randomisation
• Test the pragmatic
question of choosing
between sugared versus
sweetened sodas
Response to “treatment”
• Type of soda did not impact on thirst,
hunger, concentration or energy levels
• These variables correlated with:
631 consented &
filled baseline
questionnaire
by collaborators of the
Clinical Trial Unit of
Lausanne
* 5-point Likert scale
• Explain RCTs to the public
RESULTS
Info / consent
- demographic data
- hunger, thirst,
concentration, energy *
- drink/food habits *
STUDY AIMS
•
•
- 72.0% of those who received sugared soda
- 73.2% of those who received sweetened
soda
No association with soda actually received
Paradoxically, sweetened soda drinkers
were worst in guessing the soda actually
received (OR=0.68; 95%CI 0.48 to 0.98)
Acknowledgments
Pierluigi Ballabeni, Aude Erdmann, Fady Fares, Marc Maillard, Aurélie Mello,
Loredana Otgon, Bertrand Tappy, Céline Vicario, Loane Warpelin-Decrausaz
•
- pre-treatment level
- intercurrent consumption of drink / food
Globally, the taste of sugared soda was
better appreciated (p=0.04)
Exploratory/subgroup analyses
• No effect of BMI on hunger sensation
after soda consumption
• Increased hunger reported by sugared
soda drinkers (p=0.03)
• Interaction of hunger with consumption
habits:
- stimulated by sweetened soda in sweetened
soda drinkers
- stimulated by sugared soda in sugared soda
drinkers (p=0.05)
Willingness to get randomised in a
double-blind clinical trial
• 88% of included visitors would accept
to enter in a clinical trial
extremely
quite
moderatly
slightly
not at all
CONCLUSIONS
This demo RCT was effective in
raising awareness about RCTs
and EBM methods in the public
of a health fair
Neither soda showed clear
superiority regarding thirst,
hunger, concentration or energy