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

Appetite Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965210
• Other study ID #: SLU-IL-S1
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: October 21, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Swedish University of Agricultural Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite Regulation

Intervention

Other:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Swedish University of Agricultural Sciences	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Breath hydrogen and methane response	Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).	8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)	No
Secondary	Gastric emptying rate	Paracetamol (1 g) was taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.	8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)	No
Secondary	Glucose and hormonal response	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.	8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)	No
Secondary	Metabolic profiles	The flux of nutrients is measured in plasma samples.	8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)	No
Secondary	Products from bacterial fermentation of dietary fibre	Products from bacterial fermentation of dietary fibre are measured in plasma samples.	8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)	No
Secondary	Ad libitum food intake	Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.	8 h after breakfast (480 min)	No