Obesity Clinical Trial
Official title:
Clinical Evaluation to Improve Obesity Intervention Prescription: Functional Foods as a Potential Solution for Individuals With a Low Satiety Quotient Phenotype?
The global research project was organized as a clinical process starting with an evaluation aiming at the determination of a diagnosis pertaining to the degree of satiety signal capacity. It was extended by a phase of metabolic and behavioural characterization to better understand the clinical condition of the patients. The main part of the program was a weight loss intervention that was focused on high satiating foods. Finally, the process was completed by an evaluation allowing to determine the impact of the intervention on the metabolic and behavioural conditions of the patients.
Dietary restriction, being prescribed as low and very low calorie diets, has been largely
used as a strategy of dietary management of obesity. Beyond the fact that these diets fully
respect the first law of thermodynamics, they are also rather easy to supervise and they
offer a guarantee of substantial weight loss to compliant patients. Dietary restriction
strategies also carry important limitations which include their failure to take into account
appetite sensations of the obese patient. This point is important since it dictates the
extent to which the patient can tolerate his/her dietary regimen without hunger over time as
well as its related body weight loss. In this regard, experimental and clinical data show
that weight regain up to initial body weight and even more occurs over years after a
diet-induced weight loss. Moreover, evidence also revealed that restraint behaviour is
difficult to maintain over time and that a decrease in this behaviour is related to weight
gain on a long term basis. The challenge thus becomes the search of a strategy that can
promote a substantial spontaneous energy deficit without significantly altering hunger and
satiety levels as well as their related well-being. Up to now, the only approach which
emerges as having the potential to respect these two criteria is the design of functional
foods, i.e. foods with sufficient satiety-promoting properties to compensate for the
enhancing effect of body fat loss on appetite. The food specialists can rely on a catalogue
of functional ingredients that can be used to prepare functional menus in order to improve
the regulation of energy balance and body weight stability in individuals prone to obesity.
As described above, this issue would be particularly relevant for obese individuals
displaying a low satiety phenotype, i.e. individuals experiencing difficulty to match energy
intake to expenditure in a context promoting excess food intake.
The objectives of this study were to characterize obese men displaying the low satiety
phenotype (metabolic and behavioral characteristics) and to determine the impact of highly
satiating foods on body weight loss, satiety feelings and compliance in this population.
EXPERIMENTAL DESIGN
Recruitment of subjects and satiety phenotype determination
Each patient referred by a physician was contacted by phone and a first screening interview
was performed to validate the inclusion criteria. After recruitment, every subject was met
to read and sign the letter of consent as well as to discuss every aspect of the program
about which he might have some questions. We took advantage of this brief meeting to measure
height, body weight and waist circumference to determine BMI and to estimate the level of
abdominal fat.
This phase also included a 2-hour session of evaluation in order to determine satiety signal
capacity (SQ). At the end of this session, each subject completed the Three-Factor Eating
Questionnaire with the specific preoccupation to measure cognitive dietary restraint as an
exclusion criterion. The information collected in this first phase of testing was used to
subsequently classify subjects on the basis of their satiety signal capacity (low SQ vs
normal/high SQ). Subjects not selected to participate in the next phase of the project
received, in addition to their health report, a free dietary consultation focusing on the
adoption of healthy behaviours. This first phase of testing allowed to rank order subjects
on the basis of their score obtained with the satiety quotient. Seventy participants were
selected to participate in the study
Initial metabolic and behavioural characterization (Time 0)
This phase of testing began by a standard medical examination performed by the physician of
our research team several days before the main testing session. This permitted to identify
potential illnesses influencing appetite control and to evaluate the general health
condition of each subject. In order to evaluate the reproducibility over time of the satiety
quotient determination and to ascertain the status of subjects determined at the initial
evaluation, the standardized breakfast test meal was repeated. However, this test was
performed in a session of longer duration that allowed to characterize metabolic and
behavioural factors associated with a low/high satiety capacity. The measurements included
in this phase of testing were used as baseline measurements for the next phase of this
project.
Intervention study
The 70 participants were randomly assigned to either a weight loss program consisting of a
highly satiating diet (n=35) (low to moderate in fat (30-35%), high in fibres (> 25g/day),
high protein (20-25% of total energy intake) and including 45-50% energy as carbohydrate
mainly provided by foods with low glycemic index and adequate to slightly increased vitamin
and mineral intakes) which is expected to induce a spontaneous energy deficit or a diet
supervision based on the guidelines concordant with the Canadian Food Guide (n=35) (10-15,
55-60 and 30% energy as protein, carbohydrate, and lipid, respectively). For statistical
analysis, 4 subgroups have been created based on the SQ classification: 1) low SQ, high
satiating diet 2) low SQ, conventional healthy diet, 3) normal/high SQ, high satiating diet,
4) normal/high SQ, conventional healthy diet. This experimental environment thus
corresponded to a two by two factorial design in which the two independent variables are SQ
and diet. Participants were encouraged to comply with the diets for a 16-week period even if
a resistance to weight loss (i.e weight maintenance during one month) was observed during
the protocol.
Final metabolic and behavioural characterization (Post-tests; week 16)
All the measurements performed at Time 0 were repeated immediately after the 16-week
intervention period for each of the four subgroups of subjects.
POTENTIAL OUTCOME AND FUTURE PERSPECTIVES
The main conceptual outcomes of this were: 1) the characterization of factors implicated in
different satiety signal capacities; 2) the investigation of the role of individual capacity
of satiety signal in body weight loss and diet compliance, and 3) the determination of the
impact of functional menus promoting satiety to compensate for the low spontaneous satiety
level in some obese individuals. In addition, this project provided clinical and economical
outcomes. Indeed, it represented the first study documenting the weight-reducing impact of a
healthy diet based on foods whose functionality have been upgraded by food design. If this
project confirms that such a diet can promote weight loss without restriction, but while
rather being associated with well-being, this will be a major gain for clinical
nutritionists who have up to now unsuccessfully try to counteract the obesity epidemic and
who have to deal with consumers who primarily request palatable foods instead of a priori
focusing on healthy food. From an economical standpoint, this program will be a reference
source of validation for the industry seeking justifications and claims to promote healthy
foods facilitating body weight control.
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