Clinical trial NCT02090049: Appetite Regulation by a Breakfast Soft Bread
Official title: Appetite Ratings, Postprandial Glucose, Insulin and Gastrointestinal Hormone Responses After the Intake of an Enriched Fiber and Protein Breakfast Soft Bread in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Focus of the Study is Healthy Volunteers
Keywords: Appetite
Satiety
Bread
Dietary fiber
Gastrointestinal hormones
Glycemia
Insulinemia
Lead sponsor: Puratos
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Granada
First posted: 2014-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion criteria:

* Body mass index (BMI) ranging 18 and 29 (normal and moderate overweight).
* Low level of food restriction
* Daily breakfast consumption
* Daily bread consumption
* Practising standard physical activity

Exclusion criteria:

* Age lower than 18 or higher than 45
* BMI lower than 18 and higher than 29
* Smokers
* Pregnant or lactating
* Infrequent breakfast consumption Unusual bread consumption Unusual fiber intake Plasma glucose higher than 110 mg/dl Blood insulin levels higher than 10 mU/ml Blood pressure higher than 110 mmHg The use of any medication for the control of blood pressure or glucose or lipid metabolism Suffering any metabolic disorder, disorders of the gastrointestinal tract The presence of familiar dislipemias relatives of genetic character The denial to take part in the study The use of any nutritional supplement in the last 3 months Practising endurance sports. Sesame allergies Gluten intolerance/allergy

Primary outcomes:
measure: MEASUREMENT OF POSTPRANDIAL APPETITE RATINGS CHANGES
timeFrame: 0, 30, 60, 90, 120, 180, 210 and 240 min after intervention
Secondary outcomes:
measure: Determination of postprandial glycaemia, insulinaemmia and physiological markers of satiation and satiety
timeFrame: 0, 30, 60, 90, 120, 180, 210 and 240 min after intervention
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Institu of Nutrition and Food Technology "José Mataix"
Study officials:
affiliation: Universidad de Granada
name: María D Mesa, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Granada
name: Ángel Gil, Profesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Anton C, Lopez-Millan B, Rico MC, Sanchez-Rodriguez E, Ruiz-Lopez MD, Gil A, Mesa MD. An enriched, cereal-based bread affects appetite ratings and glycemic, insulinemic, and gastrointestinal hormone responses in healthy adults in a randomized, controlled trial. J Nutr. 2015 Feb;145(2):231-8. doi: 10.3945/jn.114.200386. Epub 2014 Dec 10.