Clinical trial NCT02011217: The Effects of Rye Crisp Bread on Appetite and Metabolic Function
Official title: The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Regulation
Keywords: Rye
Dietary Fibre
Bread
Crisp bread
Appetite
Satiety
Hunger
Desire to eat
Metabolism
Glucose
Insulin
Gut hormones
Gastric emptying rate
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2013-12-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.

Detailed description: The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.

Eligibility criteria: Inclusion Criteria:

* Habitual breakfast eaters

Exclusion Criteria:

* Pregnancy, lactation or wishing to become pregnant during the study period
* Dieting
* Weightloss
* Eating disorder
* Hyperglycemic
* Hyperinsulinemic
* Thyroid disease
* Metabolic issues
* Diabetes
* Physical or psychological problems with eating
* Food intolerance/allergies to foods included in the study
* Intolerance/allergy to paracetamol
* Heavy smokers
* Recent or concurrent participation in a dietary intervention research study

Primary outcomes:
measure: Subjective Appetite Profiles during 4 hours
timeFrame: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary outcomes:
measure: Gastric Emptying Rate during 4 hours
timeFrame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
measure: Hormonal Responses during 4 hours
timeFrame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
measure: Glucose and Insulin Responses during 4 hours
timeFrame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
Study officials:
affiliation: Swedish University of Agricultural Sciences
name: Rikard K Landberg, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johansson DP, Lee I, Riserus U, Langton M, Landberg R. Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. PLoS One. 2015 Mar 31;10(3):e0122241. doi: 10.1371/journal.pone.0122241. eCollection 2015.