NCT00876785

Brief Summary

The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
Last Updated

April 14, 2009

Status Verified

April 1, 2009

Enrollment Period

6 months

First QC Date

April 6, 2009

Last Update Submit

April 13, 2009

Conditions

Keywords

Rye bread satiety breakfast

Outcome Measures

Primary Outcomes (1)

  • Subjective satiety, hunger and desire to eat

    During 8 hours after intake of test meal

Study Arms (2)

1

ACTIVE COMPARATOR

Reference wheat bread breakfast

Other: wheat bread based breakfast

2

EXPERIMENTAL

Rye bread breakfast

Other: Rye bread breakfast

Interventions

A randomised, within-subject comparison design was used. Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00. Amount, type and timing of food and drink intake during the study period were standardised.

2

Reference wheat bread breakfast

1

Eligibility Criteria

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

You may qualify if:

  • age between 20 and 60 years
  • body mass index (BMI) 18-27 kg/m2
  • a habit of consuming breakfast, lunch and dinner everyday
  • fasting plasma glucose 4.0-6.1 mmol/L
  • haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
  • thyroid-stimulating hormone (TSH) 0.3-4.0 mlE/L
  • 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 of 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

Study Sites (1)

Swedish University of Agricultural Sciences

Uppsala, 75007, Sweden

Location

Related Publications (1)

  • Isaksson H, Fredriksson H, Andersson R, Olsson J, Aman P. Effect of rye bread breakfasts on subjective hunger and satiety: a randomized controlled trial. Nutr J. 2009 Aug 26;8:39. doi: 10.1186/1475-2891-8-39.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per Aman, Professor

    university

    STUDY DIRECTOR

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

April 6, 2009

First Posted

April 7, 2009

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

April 14, 2009

Record last verified: 2009-04

Locations