Clinical trial NCT02793297: Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses
Official title: Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses: A Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2016-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Subjective appetite assessed using an electronic visual analogue scale
timeFrame: 360 min after breakfast
Secondary outcomes:
measure: Glucose
timeFrame: 230 minutes after breakfast
measure: insulin
timeFrame: 230 minutes after breakfast
measure: GLP-1
timeFrame: 230 minutes after breakfast
Other outcomes:
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