Overweight and Obesity Clinical Trial
Official title:
SATIN: Satiety Innovation, Study 1
The proposed study will address the effect of developed novel food products through
processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability
and gut health using in vivo studies and validating new in vivo approaches.
Specifically in this protocol we will address, in a short human intervention study the
effect of a potentially satiating product on appetite, appetite biomarkers, particularly the
influence on gut microbiota, tolerance and safety of the products in healthy obese and
overweight volunteers in free living conditions.
Previous research has suggested that food structure and food composition has a role to play
in controlling consumption. Low-energy, high-fibre diets provide physical bulk in the
gastro-intestinal tract to sustain fullness in a way that low-volume, energy-dense foods
cannot. However, studies shown low long term acceptability be probably associated to its
poor palatability. Taste and hedonic experience remain the main drivers of consumer choice,
and the immediate sensory aspect of food products such as palatability to have greater
salience to consumers than their health promoting properties.
Changing the properties of foods merely by changing oro-sensory properties and through the
delay of gastric emptying deals with mechanisms critical to within-meal satiation and early
post meal satiety and may produce only transient suppression of hunger unless regularly
consumed and represent benefits in delivering nutritional stimuli to key parts of the
gastro-intestinal tract. The potential to manufacture change can make food structure variety
now seem near limitless due the numerous advances in food technology.
Several recent reports have associated satiety effects with fermentable fibre sources in
human dietary studies (Nillson et al., 2008, Parnell & Weimer, 2009, Willis et al 2009).
Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might
contributes to obesity (Ley et al., 2006, Turnbaugh et al., 2008, Cani et al., 2007).
However, the different mechanisms involved in lean and obese subjects are not completely
resolved (Duncan et al., 2008, Schwiertz et al., 2010). Recent evidence in experimental
animal designs indicates that changes in gut microbiota composition may be associated with
increased food intake and obesity (Vijay-Kumar et al., 2010) suggesting that satiety and
intake are influenced by the species composition of the gut microbiota.
The proposed study will address the effect of developed novel food products through
processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability
and gut health using in vivo studies and validating new in vivo approaches. Specifically in
this protocol we will address the effect of a potentially satiating product on appetite,
appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of
the products in healthy obese and overweight volunteers in free living conditions. This
study is part of the major European project launched in early 2011: SATIN, a collaborative,
large-scale project that brings together the expertise of 18 participants across Europe to
develop food products through novel food process that enhance satiety.
This short-term human nutrition study comprises in a cross-over design testing either a
potentially satiety product, resistant starch type 3 (RS3) or an equivalent amount
heterogeneous natural fibre in 24 healthy- obese volunteers, aged 18-65 years old, Body Mass
Index (BMI) between 27 and 35kg/m2 from both genders after an initial 21 day weight-loss
programme, in free- living conditions. Dietary intake, body weight, blood pressure would be
monitored through the study. Faecal, urine and blood samples will be collected to monitor,
glucose, insulin, gut peptides and assess metabolites of dietary and microbial origin. Gut
transit will be monitored in six volunteers using a wireless motility device (SmartPill™)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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