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

NCT ID: NCT01965210

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appetite Regulation

Keywords

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Porridge Bread Appetite Satiety Hunger Desire to eat Metabolism Glucose Insulin Gut hormones Metabolomics Gastric emptying rate Breath hydrogen and methane excretion Rye Fermentable dietary fibre Inulin Plant protein Gluten

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Rye + high dose inulin + low dose gluten

Rye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten.

Group Type EXPERIMENTAL

Rye + equal doses of inulin & gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Rye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten.

Group Type EXPERIMENTAL

Rye + high dose inulin + low dose gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Rye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten.

Group Type EXPERIMENTAL

Rye + high dose inulin + low dose gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Large portion of rye porridge without supplements.

Group Type EXPERIMENTAL

Rye + high dose inulin + low dose gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Small portion of rye porridge without supplements.

Group Type EXPERIMENTAL

Rye + high dose inulin + low dose gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Refined wheat bread.

Group Type ACTIVE_COMPARATOR

Rye + high dose inulin + low dose gluten

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Rye + high dose inulin + low dose gluten

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.

Intervention Type OTHER

Rye + equal doses of inulin & gluten

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.

Intervention Type OTHER

Rye + low dose inulin + high dose gluten

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.

Intervention Type OTHER

Large non-supplemented rye

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.

Intervention Type OTHER

Small non-supplemented rye

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.

Intervention Type OTHER

Refined wheat bread

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isabella Lee

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rikard K Landberg, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Swedish University of Agricultural Sciences

Locations

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

Uppsala, Uppsala County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SLU-IL-S1

Identifier Type: -

Identifier Source: org_study_id