Appetite Regulation by a Breakfast Soft Bread

NCT02090049 | Completed

• 1 other identifier: PUR-3825
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

The Focus of the Study is Healthy Volunteers

Keywords

Appetite; Satiety; Bread; Dietary fiber; Gastrointestinal hormones; Glycemia; Insulinemia

Outcome Measures

Primary Outcomes (1)

• MEASUREMENT OF POSTPRANDIAL APPETITE RATINGS CHANGES

  The behavioural markers of appetite satiation and satiety can be estimated by using two categories of behavioural parameters: subjective sensations and food consumption: * Motivation to eat or subjective sensations: by determining appetite-related self-reports include a range of measures intended to capture, over a given period, specific somatic sensations or perceived general state of hunger/repletion, motivation (desire) to eat (in general or specific food types), or prospective judgments of the quantity of food or specific foods types that could or would be eaten (Blundell et al., 2010) using 100 mm visual analogue scales (VAS) (FLint et al., 2000). * Food intakes by determining the quantity of food consumed as measured in the laboratory by means of well-controlled protocols can be considered to be an objective measure of appetite (De Graaf et al., 2004).

  0, 30, 60, 90, 120, 180, 210 and 240 min after intervention

Secondary Outcomes (1)

• Determination of postprandial glycaemia, insulinaemmia and physiological markers of satiation and satiety

  0, 30, 60, 90, 120, 180, 210 and 240 min after intervention

Study Arms (2)

Puravita Breakfast

EXPERIMENTAL

Puravita Breakfast is a high protein and high fiber soft bread that contains 22% fruit (figs, apricots, raisins and prunes), a selection of cereals: wheat, oat and spelt and no added sugar.

Dietary Supplement: Puravita Breakfast

Control breakfast

PLACEBO COMPARATOR

White bread (85g) with jam (10g) and margarine (2g) adjusted for energy, fat, and sugar levels and for energy density.

Dietary Supplement: Control

Interventions

Puravita Breakfast DIETARY_SUPPLEMENT

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.

Puravita Breakfast

Control DIETARY_SUPPLEMENT

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.

Control breakfast

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Puratos: lead
• Universidad de Granada: collaborator

Study Sites (1)

Institu of Nutrition and Food Technology "José Mataix"

Granada, Granada, 18100, Spain

Location

Related Publications (1)

• 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.

  PMID: 25644342 DERIVED

Study Officials

• María D Mesa, Dr.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

• Ángel Gil, Profesor

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 18, 2014
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

ES (1)