The Effects of Rye Crisp Bread on Appetite and Metabolic Function

Appetite Regulation Clinical Trial

— S2RBAM  

Official title:

The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011217
• Other study ID #: SLU-IL-S2
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: December 9, 2013
• Start date: August 2013
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Swedish University of Agricultural Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite Regulation

Intervention

Other:
• Rye crisp bread A
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
• Rye crisp bread B
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
• Wheat crisp bread C
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Locations

Country	Name	City	State
Sweden	Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Swedish University of Agricultural Sciences	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Appetite Profiles during 4 hours	Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS).	-30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes	No
Secondary	Gastric Emptying Rate during 4 hours	Paracetamol (1 g) taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.	-15, 15, 35, 65, 95, 125, 185, 230 minutes	No
Secondary	Hormonal Responses during 4 hours	Glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.	-15, 15, 35, 65, 95, 125, 185, 230 minutes	No
Secondary	Glucose and Insulin Responses during 4 hours	Glucose and insulin are measured in plasma samples.	-15, 15, 35, 65, 95, 125, 185, 230 minutes	No