Clinical trial NCT02770833: 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.
Official title: Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Fisheries and Aquaculture Industry Research Fund
name: National Institute of Nutrition and Seafood Research, Norway
First posted: 2016-05-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Differences in diet induced thermogenesis between the four test meals
timeFrame: 3 hours
Secondary outcomes:
measure: Satiety
timeFrame: 3 hours
measure: Food preferences
timeFrame: 3 hours
measure: Glucose
timeFrame: 3 hours
measure: Insulin
timeFrame: 3 hours
measure: Glucagon
timeFrame: 3 hours
measure: C-peptide
timeFrame: 3 hours
measure: Plasma amino acids
timeFrame: 3 hours
measure: Appetite regulating hormones
timeFrame: 3 hours
measure: Free fatty acids
timeFrame: 3 hours
measure: Glycerol
timeFrame: 3 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: Prof at the department of Nutrition, Exercise and Sports
name: Anne Raben, Prof
role: PRINCIPAL_INVESTIGATOR
References: