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NCT Number: NCT02011217

The Effects of Rye Crisp Bread on Appetite and Metabolic Function

The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.

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Key information

Conditions

Appetite Regulation Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital

Uppsala, Uppsala County, SE-751 85, Sweden

About this study

The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Habitual breakfast eaters

Exclusion criteria

  • Pregnancy, lactation or wishing to become pregnant during the study period
  • Dieting
  • Weightloss
  • Eating disorder
  • Hyperglycemic
  • Hyperinsulinemic
  • Thyroid disease
  • Metabolic issues
  • Diabetes
  • Physical or psychological problems with eating
  • Food intolerance/allergies to foods included in the study
  • Intolerance/allergy to paracetamol
  • Heavy smokers
  • Recent or concurrent participation in a dietary intervention research study

Treatment and study plan

Rye crisp bread A

Other

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Rye crisp bread B

Other

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Wheat crisp bread C

Other

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Primary outcomes

  1. Subjective Appetite Profiles during 4 hours

    Time frame: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes

    Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS).

Secondary outcomes

  1. Gastric Emptying Rate during 4 hours

    Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes

    Paracetamol (1 g) taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.

  2. Hormonal Responses during 4 hours

    Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes

    Glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.

  3. Glucose and Insulin Responses during 4 hours

    Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes

    Glucose and insulin are measured in plasma samples.

Sponsors and collaborators

Lead sponsor

Swedish University of Agricultural Sciences

Other

Collaborators

  • Uppsala University

Registry information

Official study title

The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption

Acronym: S2RBAM

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2013
Registry last updated
Dec 13, 2013

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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