Appetite Regulation by a Breakfast Soft Bread
Condition: The Focus of the Study is Healthy Volunteers
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the appetite rating of a soft bread with a high content
      of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial
      levels of glucose, insulin and gastrointestinal hormones involved in appetite control and
      insulin secretion in healthy adult volunteers.
    

Detailed description: 
      A total of 30 healthy adults (17 males and 13 females) ranging from 19 to 32 years old (mean
      age 25 ± 1), with a body mass index (BMI) ranging from 19.2 to 28.5 (mean BMI 23.3 ± 0.5)
      (normal to moderately overweight) participated in this study. To avoid the risk of reaching
      false conclusions, psychometric validations of food restrictions were determined for all
      subjects using the revised version of the Three Factor Eating Questionnaire.

      This study was carried out according to EFSA requirements [Blundell et al., 2010]. The
      subjects were instructed to refrain from alcohol and/or from performing difficult physical
      activities 48 h prior to each test day. The evening before the test day, the subjects
      consumed a standardised dinner supplied by the study team. The meal consisted of pizza and
      pineapple juice (800 kcal: protein 18%E, fat 22%E and carbohydrate 60%E). The subjects were
      instructed to not eat or drink anything other than half a litre of water after the dinner.

      After 20 min of resting, on the first day of intervention, anthropometric measurements
      (weight, height and waist circumference) were collected on subjects wearing only underwear
      and after emptying their bladder. On each day of the study, a fasting blood sample was
      acquired after the resting time, and appetites were assessed with a visual analogue scale
      (VAS).

      The subjects were instructed to consume the tested breakfast (the soft roll bread or the
      control bread plus jam and margarine) within 10 min and were allowed to drink 150 ml of
      water. The subjects immediately completed two VASs, one on meal palatability and another on
      appetite feelings. In addition, the appetite feeling VAS was repeated every 30 min until a
      total of 4 h had passed.

      The subjects were not allowed to eat or drink anything else during the 4 h of the
      intervention. They were allowed to read, study, talk or listen to quiet music, but they were
      not allowed to sleep. After the last blood extraction (4 h), an ad libitum lunch consisting
      of a standardised spaghetti Bolognese (17%E protein, 34%E fat and 49%E carbohydrate) and
      water (300 ml) was provided. The subjects were instructed to eat until comfortably satisfied.
      Food intake was registered by differences in spaghetti weight before and after lunch, and the
      energy intake was calculated afterwards. After the ad libitum lunch, the subjects completed
      two VASs, one on meal palatability and another on appetite feelings. The participants
      completed a 48-h dietary survey diary, including the food intake during the day before and
      the day of the intervention.
    

Intervention name(s): Puravita Breakfast; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study was done in duplicate i.e two different days each meal (control and experimental) separated at least one week in time. Subjects were instructed to consume the test meal within 10 min from commencement. They subsequently completed VAS on appetite sensation every 30 min until a total of 4 hours. At the end of the test day, an ad libitum lunch consisting of a standardized pizza (17E% protein, 34E% fat and 49E% carbohydrate) and water (300 ml) was served. The subjects were instructed to eat until comfortably satisfied. Food intake was registered and energy intake (EI) calculated afterwards.; The control breakfast consisted of white bread (85 g), jam (10 g) and margarine (2 g) to adjust for energy density, fat and sugar levels.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Appetite; Satiety; Bread; Dietary fiber; Gastrointestinal hormones; Glycemia; Insulinemia