Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses

Appetite Clinical Trial

Official title:

Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses: A Randomized Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793297
• Other study ID #: Barilla2
• Status: Completed
• Phase: N/A
• First received: May 29, 2016
• Last updated: June 8, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• 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 overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. In the present study, the investigators evaluated how the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and glucose responses in healthy men and women in a meal-study. The investigators characterized intervention products with regards to microstructural and chemical features in order to elucidate underlying mechanisms for potential effects observed on appetite and postprandial metabolic responses.

Description:

Two commercial whole grain rye crisp breads processed differently (unfermented and sourdough fermented) and a refined wheat control product were tested in the study. The rye crisp bread products contained similar ingredients. All products provide similar amounts of available carbohydrates (about 30g). The total amount of test product is about 50-60g.

The specific primary aim of the study: To conduct a short-term breakfast intervention study in humans (n = 24) to compare the effect of 2 high-fiber rye crisp bread products processed in different ways (sourdough fermented or unfermented) and a refined wheat control crisp bread as part of a normal breakfast on self-rated appetite, postprandial glucose and insulin concentrations. Difference in post-prandial insulin response between products is the primary endpoint.

Secondary aim (conducted if significant effects in the primary endpoint have been demonstrated): To assess changes in hormones and their relation to self-perceived satiety, hunger and desire to eat and to differences in chemical and microstructural composition of the tested foods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-30 kg/m2

• fasting plasma glucose <6.0 mmol/L,

• fasting serum insulin <11 mE/L

• serum TSH <2.5 mIE/L

• plasma LDL <5.3 mmol/L

• fasting plasma triglycerides (p-TG) <1.8 mmol/L

• habitual consumption of breakfast, lunch and dinner

Exclusion Criteria:

• smokers

• use of medications likely to affect appetite

• medical conditions involving the gastrointestinal tract

• gluten intolerance or food allergies

• physical problems with eating

• dieting or self-reported fluctuations in body weight of more than 10% three months prior to screening recent participation in a dietary study

• pregnancy

• lactation

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Appetite

Intervention

Other:
• refined wheat crisp bread
Refined wheat crisp bread (52 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
• sourdough fermented rye crisp bread
Sourdough fermented rye crisp bread (59.4 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
• unfermented rye crisp bread
Unfermented rye crisp bread (59.8 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Swedish University of Agricultural Sciences	Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective appetite assessed using an electronic visual analogue scale	Participants recorded their subjective sensation of fullness and hunger using an electronic visual analogue scale	360 min after breakfast	No
Secondary	Glucose	Plasma levels	230 minutes after breakfast	No
Secondary	insulin	Plasma levels	230 minutes after breakfast	No
Secondary	GLP-1	Plasma levels	230 minutes after breakfast	No