Protein Dose-repsonse Effect on GLP-1, PYY and Appetite in Male Subjects

NCT01561235 | Completed

• 1 other identifier: B243
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also to a greater thermogenic effect causing greater increase in core temperature. The involvement of peripheral appetite-regulating hormones has only been sparingly investigated. The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings. Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.

Conditions

Obesity

Keywords

Protein; Appetite; Satiety; Energi intake; Appetite regulating hormones; Dose-response

Outcome Measures

Primary Outcomes (1)

• Acute 4-h changes from baseline in the postprandial concentration of GLP-1

  Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes. Blood samples are analyzed for GLP-1. Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.

  Measured on 3 seperate test days in a crossover design. Each test day was seperated by >4 weeks. On each test day GLP-1 was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake

Secondary Outcomes (11)

• Acute 4-h changes from baseline in subjective appetite sensations using visual analogue scales

  Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day appetite sensations were measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.

• Acute 4-h changes from baseline in the postprandial concentration of appetite regulating hormones/peptides

  Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.

• Acute 4-h changes from baseline in the postprandial concentration of glucose

  Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.

• Acute 4-h changes from baseline in the postprandial concentration of insulin

  Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.

• Acute 4-h changes from baseline in the postprandial concentrations of lipids

  Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.

Study Arms (3)

Normal Protein

ACTIVE COMPARATOR

Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 14 E%, Fat: 30 E% and carbohydrate: 56E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste.

Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones

Medium-high protein

EXPERIMENTAL

Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 25E%, Fat: 30 E% and carbohydrate: 45E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste.

Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones

High Protein

EXPERIMENTAL

Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 50 E%, Fat: 30 E% and carbohydrate: 20E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste.

Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones

Interventions

Dose-reponse effect of protein on appetite and appetite-regulating hormones OTHER

3-arm meal study for investigation of the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible 4-h dose-response effect of protein was investigated on a number of appetite-regulating hormones/peptides, together with changes in subjective appetite sensations and sensory desires were evaluated and ad libitum energy intake.

High Protein; Medium-high protein; Normal Protein

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy,
• BMI: 18.5-40 kg/m2,
• Non-smoking,
• Nonathletic,

You may not qualify if:

• BMI \> 40 kg/m2,
• Change in smoking status,
• Daily or frequent use of medication,
• Suffering from metabolic diseases,
• Suffering from psychiatric diseases,
• Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
• Blood pressure was above 150/90 mmHg,
• Hemoglobin \< 8 mmol/l.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of human Nutrition

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• Belza A, Ritz C, Sorensen MQ, Holst JJ, Rehfeld JF, Astrup A. Contribution of gastroenteropancreatic appetite hormones to protein-induced satiety. Am J Clin Nutr. 2013 May;97(5):980-9. doi: 10.3945/ajcn.112.047563. Epub 2013 Mar 6.

  PMID: 23466396 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne Astrup, Professor, Dr Med

  Depertment of Human Nutrition, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 22, 2012
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

DK (1)