NCT02793297

Brief Summary

The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. In the present study, the investigators evaluated how the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and glucose responses in healthy men and women in a meal-study. The investigators characterized intervention products with regards to microstructural and chemical features in order to elucidate underlying mechanisms for potential effects observed on appetite and postprandial metabolic responses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

May 29, 2016

Last Update Submit

June 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Subjective appetite assessed using an electronic visual analogue scale

    Participants recorded their subjective sensation of fullness and hunger using an electronic visual analogue scale

    360 min after breakfast

Secondary Outcomes (3)

  • Glucose

    230 minutes after breakfast

  • insulin

    230 minutes after breakfast

  • GLP-1

    230 minutes after breakfast

Study Arms (3)

refined wheat crisp bread

EXPERIMENTAL

refined wheat crisp bread was served as part of a complete standardized breakfast

Other: refined wheat crisp bread

sourdough fermented rye crisp bread

EXPERIMENTAL

Sourdough fermented rye crisp bread was served as part of a complete standardized breakfast

Other: sourdough fermented rye crisp bread

unfermented rye crisp bread

EXPERIMENTAL

Unfermented rye crisp bread was served as part of a complete standardized breakfast

Other: unfermented rye crisp bread

Interventions

Refined wheat crisp bread (52 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).

refined wheat crisp bread

Sourdough fermented rye crisp bread (59.4 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).

sourdough fermented rye crisp bread

Unfermented rye crisp bread (59.8 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).

unfermented rye crisp bread

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18.5-30 kg/m2
  • fasting plasma glucose \<6.0 mmol/L,
  • fasting serum insulin \<11 mE/L
  • serum TSH \<2.5 mIE/L
  • plasma LDL \<5.3 mmol/L
  • fasting plasma triglycerides (p-TG) \<1.8 mmol/L
  • habitual consumption of breakfast, lunch and dinner

You may not qualify if:

  • smokers
  • use of medications likely to affect appetite
  • medical conditions involving the gastrointestinal tract
  • gluten intolerance or food allergies
  • physical problems with eating
  • dieting or self-reported fluctuations in body weight of more than 10% three months prior to screening recent participation in a dietary study
  • pregnancy
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 29, 2016

First Posted

June 8, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06