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Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults. (FINS)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fish and carbohydrats with low or high GI
Veal and carbohydrats with low or high GI
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Proteins (seafood and meat), GI, Energy expenditure, Energy balance, Thermogenesis (DIT), Appetite regulating hormones, Appetite sensations, Glucose allostatis, Amino acid metabolism, Satiety, Food preferences

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men and women
  • Between 18 and 50 years of age
  • BMI between 25.0 and 30.0 kg×m-2
  • Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit)
  • Non-smoker

Exclusion Criteria:

  • Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
  • Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
  • Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
  • Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
  • Menopausal women and women with an irregular menstrual cycle
  • Food allergies
  • Substance abuse
  • Vigorous physical activity more than 10 hours/week
  • Alcohol intake above the recommendations from the Danish Health and Medicines Authority
  • Caffeine intake above 300 mg/day
  • Night- or shift work
  • Blood donation <1 month before study commencement and during study period
  • Simultaneous participation in other clinical studies
  • Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
  • Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Salmon vs. veal and CHO with low or high GI

Cod vs. veal and CHO with low or high GI

Arm Description

In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with salmon served with tomato sauce and other accompaniments with low GI Meat balls with salmon served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI

In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with codfish served with tomato sauce and other accompaniments with low GI Meat balls with codfish served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI

Outcomes

Primary Outcome Measures

Differences in diet induced thermogenesis between the four test meals
In the following three hours after eating the test meal respiratory gas exchange will be measured 6x25 minutes with 5 minutes breaks in between each measurement. Diet induced thermogenesis (DIT) will be measured by indirect calorimetry using a ventilated hood system. Each measurement will last for 25 minutes of which the last 20 minutes will be used for calculation of energy expenditure.

Secondary Outcome Measures

Satiety
Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)
Food preferences
In an attempt to measure spontaneous energy intake and macronutrient preferences in an experimental context, the participants will be given an ad libitum buffet lunch at noon. A cold and hot buffet-style lunch comprising a variety of foods (representing a wide selection of food groups) will be offered after the last measurement of gas exchange and the participants will be instructed to eat ad libitum.
Glucose
Blood sample
Insulin
Blood sample
Glucagon
Blood sample
C-peptide
Blood sample
Plasma amino acids
Blood samples
Appetite regulating hormones
e.g. glucagon-like peptide-1 (GLP-1)
Free fatty acids
Blood sample
Glycerol
Blood sample

Full Information

First Posted
October 29, 2014
Last Updated
May 17, 2016
Sponsor
University of Copenhagen
Collaborators
The Fisheries and Aquaculture Industry Research Fund, National Institute of Nutrition and Seafood Research, Norway
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1. Study Identification

Unique Protocol Identification Number
NCT02770833
Brief Title
Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.
Acronym
FINS
Official Title
Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Fisheries and Aquaculture Industry Research Fund, National Institute of Nutrition and Seafood Research, Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety. The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Proteins (seafood and meat), GI, Energy expenditure, Energy balance, Thermogenesis (DIT), Appetite regulating hormones, Appetite sensations, Glucose allostatis, Amino acid metabolism, Satiety, Food preferences

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salmon vs. veal and CHO with low or high GI
Arm Type
Experimental
Arm Description
In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with salmon served with tomato sauce and other accompaniments with low GI Meat balls with salmon served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI
Arm Title
Cod vs. veal and CHO with low or high GI
Arm Type
Experimental
Arm Description
In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with codfish served with tomato sauce and other accompaniments with low GI Meat balls with codfish served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI
Intervention Type
Other
Intervention Name(s)
Fish and carbohydrats with low or high GI
Intervention Type
Other
Intervention Name(s)
Veal and carbohydrats with low or high GI
Primary Outcome Measure Information:
Title
Differences in diet induced thermogenesis between the four test meals
Description
In the following three hours after eating the test meal respiratory gas exchange will be measured 6x25 minutes with 5 minutes breaks in between each measurement. Diet induced thermogenesis (DIT) will be measured by indirect calorimetry using a ventilated hood system. Each measurement will last for 25 minutes of which the last 20 minutes will be used for calculation of energy expenditure.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Satiety
Description
Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)
Time Frame
3 hours
Title
Food preferences
Description
In an attempt to measure spontaneous energy intake and macronutrient preferences in an experimental context, the participants will be given an ad libitum buffet lunch at noon. A cold and hot buffet-style lunch comprising a variety of foods (representing a wide selection of food groups) will be offered after the last measurement of gas exchange and the participants will be instructed to eat ad libitum.
Time Frame
3 hours
Title
Glucose
Description
Blood sample
Time Frame
3 hours
Title
Insulin
Description
Blood sample
Time Frame
3 hours
Title
Glucagon
Description
Blood sample
Time Frame
3 hours
Title
C-peptide
Description
Blood sample
Time Frame
3 hours
Title
Plasma amino acids
Description
Blood samples
Time Frame
3 hours
Title
Appetite regulating hormones
Description
e.g. glucagon-like peptide-1 (GLP-1)
Time Frame
3 hours
Title
Free fatty acids
Description
Blood sample
Time Frame
3 hours
Title
Glycerol
Description
Blood sample
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women Between 18 and 50 years of age BMI between 25.0 and 30.0 kg×m-2 Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit) Non-smoker Exclusion Criteria: Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast) Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months. Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period Menopausal women and women with an irregular menstrual cycle Food allergies Substance abuse Vigorous physical activity more than 10 hours/week Alcohol intake above the recommendations from the Danish Health and Medicines Authority Caffeine intake above 300 mg/day Night- or shift work Blood donation <1 month before study commencement and during study period Simultaneous participation in other clinical studies Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Raben, Prof
Organizational Affiliation
Prof at the department of Nutrition, Exercise and Sports
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.

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