NCT02093481

Brief Summary

The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for early_phase_1 obesity

Timeline
Completed

Started Feb 2014

Shorter than P25 for early_phase_1 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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

March 10, 2014

Last Update Submit

June 25, 2014

Conditions

ObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (4)

  • Blood glucose

    The test products are both ingested one day and three days prior to measurements of variables.

    Postprandial 0-180 min after breakfast

  • Insulin

    The test products are both ingested one day and three days prior to measurements of variables.

    Postprandial 0-180 min after breakfast

  • Appetite hormones

    The test products are both ingested one day and three days prior to measurements of variables.

    Postprandial 0-180 min after breakfast

  • Markers of colonic fermentation and inflammation

    The test products are both ingested one day and three days prior to measurements of variables.

    Postprandial 0-180 min after breakfast

Secondary Outcomes (1)

  • Subjective satiety

    Postprandial 0-180 min after breakfast

Study Arms (4)

+ ind. CHO + prim

EXPERIMENTAL

Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)

Other: Test mealOther: Priming

- ind. CHO + prim

EXPERIMENTAL

Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)

Other: ReferenceOther: Priming

+ ind. CHO - prim

EXPERIMENTAL

Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)

Other: Test mealOther: No priming

- ind. CHO - prim

EXPERIMENTAL

Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).

Other: ReferenceOther: No priming

Interventions

Test mealOTHER
+ ind. CHO + prim+ ind. CHO - prim
ReferenceOTHER
- ind. CHO + prim- ind. CHO - prim
PrimingOTHER

The reference or test meal was eaten 3 days prior to measurements of variables.

+ ind. CHO + prim- ind. CHO + prim
No primingOTHER

The reference or test meal was eaten 1 days prior to measurements of variables.

+ ind. CHO - prim- ind. CHO - prim

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal fasting blood glucose, BMI 19-25 kg/m2

You may not qualify if:

  • Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Nutrition and Food Chemistry, Lund Univeristy

Lund, SE, 221 00, Sweden

Location

Related Publications (1)

  • Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.

    PMID: 26990559DERIVED

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Anne Nilsson, PhD

    Lund Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, postgraduate student

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 21, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

SE(1)