Breakfast Test Products and Acute Satiety Scores
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are
      more overweight than underweight people in the world. This is partly caused by increased
      energy, or food intake. One of the physiological factors regulating the food intake pattern
      is satiety. Though the regulation of food intake has been studied quite extensively, the
      underlying mechanisms are not well elucidated yet and still new factors involved in this
      regulation are being found. Therefore, in this study the investigators aim to develop an in
      vitro screening tool combined with an in silico model for prediction of satiety, for cost-
      and time - effective screening of satiating properties of new and existing complex food
      products and (functional) ingredients, based on actual satiety scores measured. A second aim
      of the Wholegrain Satiety project is to evaluate satiating properties of different types of
      wholegrain breads and other oat based products, both for validation purposes and to
      strengthen the scientific evidence for health benefits of wholegrain products. As part of
      this study, acute satiety scores after consumption of various breakfast products in
      well-controlled clinical conditions will be compared with satiety scores obtained in 'at
      home' test conditions.

      Objective: The current study aims to compare the acute satiety effect of carbohydrate
      breakfast products.
    

Detailed description: 
      In the present study the investigators will conduct a clinical trial in which a standard
      protocol will be used to examine five different breakfasts (different in type: breakfast
      cereals and bread, and macronutrient composition) with satiating ingredients which will
      reveal actual human satiety scores. The visual analogue scales used for determination of
      satiety feelings is an accepted method by EFSA and studied extensively. It is used by TNO in
      an earlier carbohydrate containing breakfast experiment.

      Subjects may feel and eat differently at home. Especially since supervision by a researcher
      is known to influence behavior of participants. Self-measuring has the potential of giving
      more reliable estimates of intervention effects. Therefore, it is interesting to repeat the
      tests that are performed in the clinical unit, in an 'at home' condition, because that is the
      place consumers eat their breakfast habitually (= ecological validity).

      Study design: The study is designed as an open, randomized, controlled, cross-over trial.

      Study population: Forty healthy, lean and overweight, non-restrained eating women.

      Intervention: The intervention consists of five different normal breakfasts (normal amount,
      about 243-355 kCal; bread, cooked oatmeal, cereal meal, fried egg with bread) provided as a
      breakfast in the metabolic ward and at home.

      Main study parameters/endpoints: Satiety scores will be obtained with visual analogue rating
      scales (VAS). Subjects will rate hunger feelings, fullness feelings, satiety feelings, desire
      to eat and rate their prospective food consumption, before and multiple times after
      consumption of a breakfast. A test session lasts for four hours (t = 0, 15, 30, 45, 60, 90,
      120, 150, 180, 210 and 240 minutes).

      In the controlled conditions at TNO, finger pricks will be performed at t = 0, 30, 60, 90 and
      120 minutes after breakfast consumption to measure blood glucose.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Subjects will consume prescribed, standardized breakfast products; five times at
      a clinical unit and five times at home. No risk is associated with intake of the test
      products. The VAS questionnaire will be filled in on the laptop multiple times on all test
      days (at home and at the clinic). No risk or real burden is of concern in this study.
      Subjects will perform finger pricks five times in each controlled session at TNO, what is
      known as a minimally invasive technique to obtain drops of blood.
    

Intervention name(s): whole wheat bread yeast basis; Oatmeal; Cheerios; whole wheat sourdough bread; standard breakfast
Intervention type(s): Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: satiety; overweight; breakfast; ecological validity