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Completed

NCT Number: NCT02793297

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

refined wheat crisp bread

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

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

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Glucose

    Time frame: 230 minutes after breakfast

    Plasma levels

  2. insulin

    Time frame: 230 minutes after breakfast

    Plasma levels

  3. GLP-1

    Time frame: 230 minutes after breakfast

    Plasma levels

Sponsors and collaborators

Lead sponsor

Swedish University of Agricultural Sciences

Other

Collaborators

  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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