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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01965210
Enrollment
22
Registered
2013-10-18
Start date
2013-03-31
Completion date
2013-08-31
Last updated
2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed 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.

Interventions

OTHERRye + 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.

OTHERRye + 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.

OTHERRye + 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.

OTHERLarge 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.

OTHERSmall 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.

OTHERRefined 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.

Sponsors

Uppsala University
CollaboratorOTHER
Swedish University of Agricultural Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective appetite profiles8 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

MeasureTime frameDescription
Gastric emptying rate8 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.
Glucose and hormonal response8 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.
Breath hydrogen and methane response8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).
Products from bacterial fermentation of dietary fibre8 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.
Ad libitum food intake8 h after breakfast (480 min)Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.
Metabolic profiles8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)The flux of nutrients is measured in plasma samples.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026