NCT01042418

Brief Summary

Food structure influence metabolic response including appetite. Whole grain foods include a wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in foods such as breads, breakfast cereals and pasta.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Status
completed

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

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

January 4, 2010

Last Update Submit

January 4, 2010

Conditions

Obesity Prevention

Keywords

satietygrain structurerye

Outcome Measures

Primary Outcomes (1)

  • Subjective appetite (hunger, satiety, desire to eat)

    8 hours

Study Arms (3)

Whole kernel breakfast

EXPERIMENTAL
Other: Effect of breakfasts with whole vs milled rye kernels on appetite

Wheat reference breakfast

PLACEBO COMPARATOR
Other: Effect of breakfasts with whole vs milled rye kernels on appetite

Milled kernel breakfast

ACTIVE COMPARATOR
Other: Effect of breakfasts with whole vs milled rye kernels on appetite

Interventions

Effect of breakfasts with whole vs milled rye kernels on appetiteOTHER

Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design

Milled kernel breakfastWheat reference breakfastWhole kernel breakfast

Eligibility Criteria

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

You may qualify if:

  • and 60 years;
  • body mass index (BMI) 18-27 kg/m2;
  • habit of consuming breakfast, lunch and dinner every day
  • 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 of body weight more than 10% three months prior to screening;
  • consumption of any restricted diet such as vegan, gluten free, slimming etc.;
  • pregnancy, lactation or wish to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Isaksson H, Rakha A, Andersson R, Fredriksson H, Olsson J, Aman P. Rye kernel breakfast increases satiety in the afternoon - an effect of food structure. Nutr J. 2011 Apr 11;10:31. doi: 10.1186/1475-2891-10-31.

    PMID: 21481225DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

January 5, 2010

Record last verified: 2010-01