ClinicalTrials.gg
CompletedNCT02770833FINSUpdated May 18, 2016

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.

An interventional study of Fish and carbohydrats with low or high GI and Veal and carbohydrats with low or high GI in Overweight, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 48 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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

Interventions

  • OtherFish and carbohydrats with low or high GI
  • OtherVeal and carbohydrats with low or high GI
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 hours

Secondary outcomes

  1. Satiety

    Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)

    Time frame: 3 hours

  2. 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.

    Time frame: 3 hours

  3. Glucose

    Blood sample

    Time frame: 3 hours

  4. Insulin

    Blood sample

    Time frame: 3 hours

  5. Glucagon

    Blood sample

    Time frame: 3 hours

  6. C-peptide

    Blood sample

    Time frame: 3 hours

  7. Plasma amino acids

    Blood samples

    Time frame: 3 hours

  8. Appetite regulating hormones

    e.g. glucagon-like peptide-1 (GLP-1)

    Time frame: 3 hours

  9. Free fatty acids

    Blood sample

    Time frame: 3 hours

  10. Glycerol

    Blood sample

    Time frame: 3 hours

07

Study locations

1 site
  • Department of Nutrition, Exercise and Sports
    Copenhagen, Frederiksberg 1958, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2014, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2014
First posted
May 12, 2016
Start
Aug 2014
Primary completionActual
Jan 2016
CompletionActual
Jan 2016
Last update
May 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02770833
Collaborators
The Fisheries and Aquaculture Industry Research Fund, National Institute of Nutrition and Seafood Research, Norway
Responsible party
Anne Birgitte Raben (Professor, University of Copenhagen) — Principal investigator
First posted
May 12, 2016
Start date
Aug 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 18, 2016

Study contacts

Anne Raben, Prof
principal investigator · Prof at the department of Nutrition, Exercise and Sports

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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