Acute Effect of Cheeses With Different Energy Content on Appetite

NCT02582723 | Completed

• 1 other identifier: B323
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomised crossover design will be employed with three experimental conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low protein/high fat creme cheese served at least 7 days apart. After having successfully completed screening procedures, eligible participants will be invited for three separate test days. The test days should be performed at least 7 days apart; however for logistical reasons 4 days can be accepted. On the test days, the products will be provided in a randomized order, and subjective appetite ratings will be measured every 30 minutes for the following 3 hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours following serving of the breakfast meal.

Conditions

Appetite; Lack or Loss, Nonorganic Origin

Outcome Measures

Primary Outcomes (1)

• Total accumulated energy intake (overall intake of kJ from breakfast and ad libitum meal)

  The primary outcome of the study is the total accumulated energy intake including the breakfast meal and the ad libitum test meal.

  During the three hour study day

Secondary Outcomes (2)

• Feelings of appetite

  During the three hour study day

• Pleasantness of meals and test products

  After completing each meal at every test day , up to 200 minutes

Study Arms (3)

High protein/high fat hard cheese

ACTIVE COMPARATOR

Served for breakfast together with bread, juice and coffee, tea or water

Other: High protein/high fat hard cheese

High protein/low fat hard cheese

ACTIVE COMPARATOR

Served for breakfast together with bread, juice and coffee, tea or water

Other: High protein/low fat hard cheese

Low protein/high fat creme cheese

EXPERIMENTAL

Served for breakfast together with bread, juice and coffee, tea or water

Other: Low protein/high fat creme cheese

Interventions

High protein/high fat hard cheese OTHER

Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.

High protein/high fat hard cheese

High protein/low fat hard cheese OTHER

Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.

High protein/low fat hard cheese

Low protein/high fat creme cheese OTHER

Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.

Low protein/high fat creme cheese

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who have provided written informed consent
• Healthy men and women
• Ages between 18 and 60 years
• BMI between 20.0-31.9 kg/m2
• Regular breakfast eaters (eating breakfast ≥ 4 times a week)
• Regular menstrual periods (women only)

You may not qualify if:

• Participants not able to comply with the study protocol, including consumption of the specific study foods
• Significant health problems as judged by the investigator
• Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
• Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only)
• History of anaphylaxis to food
• Any known food allergies or food intolerance likely to affect the present study
• Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
• Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
• Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
• Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
• Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
• Participants who work in appetite or feeding related areas
• Post-menopausal (women only)

Sponsors & Collaborators

• University of Copenhagen: lead
• Fromageries Bel SA: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 1958, Denmark

Location

Study Officials

• Arne Astrup, Professor

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: October 21, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

DK (1)