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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.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02770833
Acronym
FINS
Enrollment
48
Registered
2016-05-12
Start date
2014-08-31
Completion date
2016-01-31
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERFish and carbohydrats with low or high GI
OTHERVeal and carbohydrats with low or high GI

Sponsors

The Fisheries and Aquaculture Industry Research Fund
CollaboratorOTHER
National Institute of Nutrition and Seafood Research, Norway
CollaboratorOTHER_GOV
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in diet induced thermogenesis between the four test meals3 hoursIn 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

MeasureTime frameDescription
C-peptide3 hoursBlood sample
Plasma amino acids3 hoursBlood samples
Appetite regulating hormones3 hourse.g. glucagon-like peptide-1 (GLP-1)
Free fatty acids3 hoursBlood sample
Glucagon3 hoursBlood sample
Satiety3 hoursEvaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)
Food preferences3 hoursIn 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.
Glucose3 hoursBlood sample
Insulin3 hoursBlood sample
Glycerol3 hoursBlood sample

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026