NCT01117363

Brief Summary

Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current study is to investigate whether this effects remains at regular consumption. A secondary aim is to compare the orocecal transit time (OCTT) between the two breakfasts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 5, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

May 4, 2010

Last Update Submit

May 4, 2010

Conditions

Keywords

Appetite whole grain

Outcome Measures

Primary Outcomes (1)

  • Appetite profile

    Subjective feelings of appetite (hunger, satiety and desire to eat) were assessed every 30 min, starting just before breakfast at 08:00 and continuing until bedtime. The last recording was made before breakfast on the following day.

    24 h

Secondary Outcomes (3)

  • energy intake

    3 days

  • Orocecal transit time

    8 h

  • Breath hydrogen

    8 h

Study Arms (2)

Rye porrige breakfast

EXPERIMENTAL
Other: dietary intervention (rye porridge or wheat bread)

Refined wheat reference bread breakfast

ACTIVE COMPARATOR
Other: dietary intervention (rye porridge or wheat bread)

Interventions

A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design. The two dietary intervention periods are separated by a 3-4 wks wash out.

Refined wheat reference bread breakfastRye porrige breakfast

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • man or woman aged between 20 and 60 years;
  • body mass index (BMI) 18-27 kg/m2;
  • habit of consuming breakfast, lunch and dinner every day;
  • and willingness to comply with the study procedures.

You may not qualify if:

  • intake of medicine likely to affect appetite or food intake;
  • any medical condition involving the gastrointestinal tract;
  • eating disorder;
  • smoking;
  • consumption of more than three cups of coffee per day;
  • change in body weight more than 10% during three months prior to screening;
  • consumption of any restricted diet such as vegan, gluten-free, slimming;
  • pregnancy, lactation or wish to become pregnant during the study period;
  • any known intolerance towards salazopyrin and similar substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Food Practice

Uppsala, 75183, Sweden

Location

Related Publications (1)

  • Isaksson H, Tillander I, Andersson R, Olsson J, Fredriksson H, Webb DL, Aman P. Whole grain rye breakfast - sustained satiety during three weeks of regular consumption. Physiol Behav. 2012 Feb 1;105(3):877-84. doi: 10.1016/j.physbeh.2011.10.023. Epub 2011 Oct 28.

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Per Åman, Professor

    Swedish University of Agricultural Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 5, 2010

Record last verified: 2010-05

Locations