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

June 8, 2016 updated by: Dr. Rikard Landberg, Swedish University of Agricultural Sciences

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: refined wheat crisp bread
refined wheat crisp bread was served as part of a complete standardized breakfast
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).
Experimental: sourdough fermented rye crisp bread
Sourdough fermented rye crisp bread was served as part of a complete standardized breakfast
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).
Experimental: unfermented rye crisp bread
Unfermented rye crisp bread was served as part of a complete standardized breakfast
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective appetite assessed using an electronic visual analogue scale
Time Frame: 360 min after breakfast
Participants recorded their subjective sensation of fullness and hunger using an electronic visual analogue scale
360 min after breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 230 minutes after breakfast
Plasma levels
230 minutes after breakfast
insulin
Time Frame: 230 minutes after breakfast
Plasma levels
230 minutes after breakfast
GLP-1
Time Frame: 230 minutes after breakfast
Plasma levels
230 minutes after breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 29, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Barilla2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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