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.

Overweight Clinical Trial

— FINS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770833
• Other study ID #: H-1-2014-038 (B314)
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: May 17, 2016
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Fish and carbohydrats with low or high GI

• Veal and carbohydrats with low or high GI

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	National Institute of Nutrition and Seafood Research, Norway, Norwegian Fiskeri- og Havbruksnæringens Forskningsfond (FHF)

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Satiety	Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)	3 hours	No
Secondary	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	No
Secondary	Glucose	Blood sample	3 hours	No
Secondary	Insulin	Blood sample	3 hours	No
Secondary	Glucagon	Blood sample	3 hours	No
Secondary	C-peptide	Blood sample	3 hours	No
Secondary	Plasma amino acids	Blood samples	3 hours	No
Secondary	Appetite regulating hormones	e.g. glucagon-like peptide-1 (GLP-1)	3 hours	No
Secondary	Free fatty acids	Blood sample	3 hours	No
Secondary	Glycerol	Blood sample	3 hours	No