- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793297
Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses
Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses: A Randomized Cross-over Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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