NCT02521805

Brief Summary

A randomized cross-over meal study will investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation. The study will use basic measures of ad libitum energy intake and visual-analogue scales of appetite (study A). A sub-study (study B) will additionally include blood collection from 15 of the 40 participants to investigate biological markers targeted satiety. The study days will be conducted at least one week apart to eliminate carry over effects. In the sub-study, the study days will be at least two weeks apart due to blood collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

July 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

July 9, 2015

Last Update Submit

April 29, 2016

Conditions

Healthy

Keywords

AppetiteProteinProtein qualityDietary fibreSatiety

Outcome Measures

Primary Outcomes (1)

  • Ad libitum energy intake (kJ)

    Food intake from ad libitum meal

    Acute (4 hours)

Secondary Outcomes (5)

  • Subjective appetite ratings (100 mm line scale)

    Acute (4 hours)

  • Appetite regulating hormones (analysis)

    Postprandial concentrations (4 hours)

  • Glucose (analysis)

    Postprandial concentrations (4 hours)

  • Plasma amino acids (analysis)

    Postprandial concentrations (4 hours)

  • Insulin (analysis)

    Postprandial concentrations (4 hours)

Study Arms (4)

PA

SHAM COMPARATOR

Animal protein and no fiber (control)

Other: Animal protein

PAF

EXPERIMENTAL

Animal protein added fiber

Other: Animal proteinOther: Dietary fiber (meat food matrice)

PVF

EXPERIMENTAL

Vegetable protein naturally containing dietary fiber

Other: Vegetable proteinOther: Dietary fiber (vegetable food matrice)

PAVM

EXPERIMENTAL

Animal protein and dietary fiber in meal

Other: Animal proteinOther: Dietary fiber (cereal food matrice)

Interventions

Animal proteinOTHER
PAPAFPAVM
Vegetable proteinOTHER
PVF
Dietary fiber (cereal food matrice)OTHER
PAVM
Dietary fiber (meat food matrice)OTHER
PAF
Dietary fiber (vegetable food matrice)OTHER
PVF

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who have provided written informed consent
  • Healthy men
  • Ages between 18 and 40 years
  • BMI between 18.5 and 25.0 kg/m2
  • Pork eaters

You may not qualify if:

  • Any food allergy, dislike or special diet of relevance to the study
  • Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
  • Irregular eating schedule
  • Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
  • Any known chronic diseases
  • Vigorous physical activity more than 10 hours/week
  • Smoking, smoking cessation within the past 3 months or nicotine use (\> 10 cigarettes per day)
  • Substance abuse
  • Alcohol intake above the recommendations from the Danish Health and Medicines Authority
  • Blood donation \<3 month before study start and during study period (only relevant for the sub-study)
  • Participants who work in appetite or feeding related areas
  • Participation in other intervention studies
  • Participants not able to comply with the study protocol as judged by study personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

  • Kehlet U, Kofod J, Holst JJ, Ritz C, Aaslyng MD, Raben A. Addition of Rye Bran and Pea Fiber to Pork Meatballs Enhances Subjective Satiety in Healthy Men, but Does Not Change Glycemic or Hormonal Responses: A Randomized Crossover Meal Test Study. J Nutr. 2017 Sep;147(9):1700-1708. doi: 10.3945/jn.117.250332. Epub 2017 Aug 9.

    PMID: 28794212DERIVED

MeSH Terms

Interventions

Plant Proteins, DietaryDietary Fiber

Intervention Hierarchy (Ancestors)

Dietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary CarbohydratesCarbohydrates

Study Design

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

Study Record Dates

First Submitted

July 9, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

DK(1)