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)

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Other: Fish and carbohydrats with low or high GI; Other: Veal and carbohydrats with low or high GI

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 1958
      • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salmon vs. veal and CHO with low or high GI; 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	Other: Fish and carbohydrats with low or high GI; Other: Veal and carbohydrats with low or high GI
Experimental: Cod vs. veal and CHO with low or 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	Other: Fish and carbohydrats with low or high GI; Other: Veal and carbohydrats with low or high GI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)	3 hours
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.	3 hours
Glucose	Blood sample	3 hours
Insulin	Blood sample	3 hours
Glucagon	Blood sample	3 hours
C-peptide	Blood sample	3 hours
Plasma amino acids	Blood samples	3 hours
Appetite regulating hormones	e.g. glucagon-like peptide-1 (GLP-1)	3 hours
Free fatty acids	Blood sample	3 hours
Glycerol	Blood sample	3 hours

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: The Fisheries and Aquaculture Industry Research Fund; National Institute of Nutrition and Seafood Research, Norway
• Investigators: Principal Investigator: Anne Raben, Prof, Prof at the department of Nutrition, Exercise and Sports

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Energy expenditure; Satiety; Energy balance; GI; Amino acid metabolism; Appetite regulating hormones; Appetite sensations; Food preferences; Proteins (seafood and meat); Thermogenesis (DIT); Glucose allostatis
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: H-1-2014-038 (B314)