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

NCT01965210 | Completed

• 1 other identifier: SLU-IL-S1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appetite Regulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Subjective appetite profiles

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

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

Secondary Outcomes (6)

• Breath hydrogen and methane response

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

• Gastric emptying rate

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

• Glucose and hormonal response

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

• Metabolic profiles

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

• Products from bacterial fermentation of dietary fibre

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

Study Arms (6)

Rye + high dose inulin + low dose gluten

EXPERIMENTAL

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

Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread

Rye + equal doses of inulin & gluten

EXPERIMENTAL

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

Other: Rye + high dose inulin + low dose gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread

Rye + low dose inulin + high dose gluten

EXPERIMENTAL

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

Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread

Large non-supplemented rye

EXPERIMENTAL

Large portion of rye porridge without supplements.

Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Small non-supplemented rye; Other: Refined wheat bread

Small non-supplemented rye

EXPERIMENTAL

Small portion of rye porridge without supplements.

Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Refined wheat bread

Refined wheat bread

ACTIVE COMPARATOR

Refined wheat bread.

Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye

Interventions

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.

Large non-supplemented rye; Refined wheat bread; Rye + equal doses of inulin & gluten; Rye + low dose inulin + high dose gluten; Small non-supplemented rye

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.

Large non-supplemented rye; Refined wheat bread; Rye + high dose inulin + low dose gluten; Rye + low dose inulin + high dose gluten; Small non-supplemented rye

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; Refined wheat bread; Rye + equal doses of inulin & gluten; Rye + high dose inulin + low dose gluten; Small non-supplemented rye

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.

Refined wheat bread; Rye + equal doses of inulin & gluten; Rye + high dose inulin + low dose gluten; Rye + low dose inulin + high dose gluten; Small non-supplemented rye

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.

Large non-supplemented rye; Refined wheat bread; Rye + equal doses of inulin & gluten; Rye + high dose inulin + low dose gluten; Rye + low dose inulin + high dose gluten

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.

Large non-supplemented rye; Rye + equal doses of inulin & gluten; Rye + high dose inulin + low dose gluten; Rye + low dose inulin + high dose gluten; Small non-supplemented rye

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish University of Agricultural Sciences: lead
• Uppsala University: collaborator

Study Sites (1)

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

Uppsala, Uppsala County, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Inulin; Glutens

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Rikard K Landberg, Ass. Prof.

  Swedish University of Agricultural Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: October 18, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

SE (1)