Skip to main content
OpenTrials
Completed

NCT Number: NCT01965210

The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function

Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 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 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast. The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels. The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Hormonal responses, changes in the metabolome and fermentation products 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

  • Women must be post-menopausal or habitually take hormonal contraceptives
  • Habitual breakfast eaters

Exclusion criteria

  • Non-contraceptive use among pre-menopausal women
  • 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 eating
  • Food intolerances/allergies to foods included in the study
  • Vegetarians
  • Intolerance/allergy to paracetamol
  • Heavy smokers
  • Recent or concurrent participation in an intervention research study

Treatment and study plan

Rye + high dose inulin + low dose gluten

Other

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

Rye + equal doses of inulin & gluten

Other

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

Rye + low dose inulin + high dose gluten

Other

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

Large non-supplemented rye

Other

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

Small non-supplemented rye

Other

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

Refined wheat bread

Other

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

Primary outcomes

  1. Subjective appetite profiles

    Time frame: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)

    Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).

Secondary outcomes

  1. Breath hydrogen and methane response

    Time frame: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)

    Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).

  2. Gastric emptying rate

    Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)

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

  3. Glucose and hormonal response

    Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)

    Glucose, insulin, 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.

  4. Metabolic profiles

    Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)

    The flux of nutrients is measured in plasma samples.

  5. Products from bacterial fermentation of dietary fibre

    Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)

    Products from bacterial fermentation of dietary fibre are measured in plasma samples.

  6. Ad libitum food intake

    Time frame: 8 h after breakfast (480 min)

    Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.

Sponsors and collaborators

Lead sponsor

Swedish University of Agricultural Sciences

Other

Collaborators

  • Uppsala University

Registry information

Official study title

The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Oct 22, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.