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

NCT ID: NCT02793297

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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.

Conditions

Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

refined wheat crisp bread

refined wheat crisp bread was served as part of a complete standardized breakfast

Group Type: EXPERIMENTAL

refined wheat crisp bread

Intervention Type: OTHER

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 was served as part of a complete standardized breakfast

Group Type: EXPERIMENTAL

sourdough fermented rye crisp bread

Intervention Type: OTHER

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 was served as part of a complete standardized breakfast

Group Type: EXPERIMENTAL

unfermented rye crisp bread

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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).

Intervention Type: OTHER

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rikard Landberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Barilla2

Identifier Type: -

Identifier Source: org_study_id