Enhanced Satiety With Pork Products Containing Dietary Fibre (SAPO)

April 29, 2016 updated by: Anne Birgitte Raben, University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dietary proteins have shown to be the most satiating macronutrient, however it is not clear whether various types of protein exert the same effect. The latest evidence on animal versus plant proteins show no differences on appetite and ad libitum energy intake, neither on weight loss but well-designed studies that control for macronutrient composition of protein-rich foods are rare and therefore needed.

Dietary fibre have also shown to play a role in appetite regulation, especially viscous dietary fibre have a greater effect on short-term satiety and subsequent energy intake than less viscous dietary fibers. A combination of dietary fibre and protein would therefore be beneficial in formulation of satiety-enhancing foods targeted consumers who want to maintain or loose weight.

Pork is a good source of high-quality protein and essential vitamins and minerals. The fat content of most retail pork cuts lives up to the Nordic Key Hole nutrition label having less than 10 g fat per 100 gram. Pork can therefore be recognized as a lean meat type delivering key nutrients as part of the diet. Processed pork products such as sausages, liver pate and salamis are nutritionally characterized as high-fat products. However, today the meat industry puts a lot of effort into product development of meat products with a healthier nutritional profile.

The investigators have previously shown that the addition of wheat and rye bran to sausages with 10% fat reduced appetite sensations. Also, the satisfying effect of dietary fibers was more pronounced when added to sausages than when added to bread. These findings point towards a potential for using dietary fibre in meat products in order to improve the nutritional profile of the product as well as the satiating effects.

The overall objective is to investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation. Dietary protein and fibre will be combined into an animal protein based food (fiber-meat balls), a vegetable protein based food (veggie "meat balls"), a meal (meat balls with fiber bread) and compared to animal protein per se (meat balls). The study will use measures of ad libitum energy intake and visual-analogue scales of appetite in combination with biological markers targeted satiety.

This study will contribute to a substantial increase in the knowledge on macronutrients and their stimulating effects on appetite-regulating hormones. The study will focus on healthy and palatable pork products containing dietary fibre in order to be applicable to the food industry. The current evidence supports the need for satiating-enhancing foods high in protein and dietary fibre. However, macronutrients and their stimulating effects on appetite-regulating hormones have not been adequately investigated in well-controlled studies using real foods. Likewise, there is no clear evidence that animal protein is superior to vegetable protein with regard to their satiating effects on appetite and appetite-regulating hormones.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: PA
Animal protein and no fiber (control)
Other: Animal protein
Experimental: PAF
Animal protein added fiber
Other: Animal protein
Other: Dietary fiber (meat food matrice)
Experimental: PVF
Vegetable protein naturally containing dietary fiber
Other: Vegetable protein
Other: Dietary fiber (vegetable food matrice)
Experimental: PAVM
Animal protein and dietary fiber in meal
Other: Animal protein
Other: Dietary fiber (cereal food matrice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad libitum energy intake (kJ)
Time Frame: Acute (4 hours)
Food intake from ad libitum meal
Acute (4 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective appetite ratings (100 mm line scale)
Time Frame: Acute (4 hours)
Acute (4 hours)
Appetite regulating hormones (analysis)
Time Frame: Postprandial concentrations (4 hours)
Postprandial concentrations (4 hours)
Glucose (analysis)
Time Frame: Postprandial concentrations (4 hours)
Postprandial concentrations (4 hours)
Plasma amino acids (analysis)
Time Frame: Postprandial concentrations (4 hours)
Postprandial concentrations (4 hours)
Insulin (analysis)
Time Frame: Postprandial concentrations (4 hours)
Postprandial concentrations (4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Meat Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B316 SAPO 2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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