OverweightFINSNCT02770833
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.
A study testing Fish and carbohydrats with low or high GI and Veal and carbohydrats with low or high GI in people with Overweight, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Fish and carbohydrats with low or high GI and Veal and carbohydrats with low or high GI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
Official title: 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.
- Conditions
- Overweight
- Being tested
- Fish and carbohydrats with low or high GI, Veal and carbohydrats with low or high GI
- 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
- Medical subject headings
- Overweight, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish and carbohydrats with low or high GIOther
Veal and carbohydrats with low or high GIOther
| Study group | Role | What they receive |
|---|---|---|
| Salmon vs. veal and CHO with low or high GI | Experimental | 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 Receives: Other: Fish and carbohydrats with low or high GI; Other: Veal and carbohydrats with low or high GI |
| Cod vs. veal and CHO with low or high GI | Experimental | 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 Receives: Other: Fish and carbohydrats with low or high GI; Other: Veal and carbohydrats with low or high GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (10)
Satiety
Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)
Measured: 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.
Measured: 3 hours
Glucose
Blood sample
Measured: 3 hours
Insulin
Blood sample
Measured: 3 hours
Glucagon
Blood sample
Measured: 3 hours
C-peptide
Blood sample
Measured: 3 hours
Plasma amino acids
Blood samples
Measured: 3 hours
Appetite regulating hormones
e.g. glucagon-like peptide-1 (GLP-1)
Measured: 3 hours
Free fatty acids
Blood sample
Measured: 3 hours
Glycerol
Blood sample
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Fisheries and Aquaculture Industry Research Fund, National Institute of Nutrition and Seafood Research, Norway
- Responsible party
- Principal investigator, Anne Birgitte Raben, University of Copenhagen
- Investigators
- Anne Raben, Prof, Principal investigator, Prof at the department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770833
- Sponsor's protocol ID
- H-1-2014-038 (B314)
- Acronym
- FINS
- Status last verified
- May 2016
- First submitted
- 29 Oct 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.
- ClinicalTrials.gov ID
- NCT02770833
- Acronym / sponsor ID
- FINS / H-1-2014-038 (B314)
- Conditions
- Overweight
- Keywords
- Proteins (seafood and meat), GI, Energy expenditure, Energy balance, Thermogenesis (DIT), Appetite regulating hormones, Appetite sensations, Glucose allostatis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Fisheries and Aquaculture Industry Research Fund, National Institute of Nutrition and Seafood Research, Norway
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmon vs. veal and CHO with low or high GI | Experimental | Other: Fish and carbohydrats with low or high GI, Other: Veal and carbohydrats with low or high GIIn 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 |
| Cod vs. veal and CHO with low or high GI | Experimental | Other: Fish and carbohydrats with low or high GI, Other: Veal and carbohydrats with low or high GIIn 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish and carbohydrats with low or high GI | Other | Cod vs. veal and CHO with low or high GI, Salmon vs. veal and CHO with low or high GI |
| Veal and carbohydrats with low or high GI | Other | Cod vs. veal and CHO with low or high GI, Salmon vs. veal and CHO with low or high GI |
Primary outcome
Differences in diet induced thermogenesis between the four test meals
Time frame: 3 hours
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.
10 secondary outcomes
Satiety
Time frame: 3 hours
Food preferences
Time frame: 3 hours
Glucose
Time frame: 3 hours
Insulin
Time frame: 3 hours
Glucagon
Time frame: 3 hours
C-peptide
Time frame: 3 hours
Plasma amino acids
Time frame: 3 hours
Appetite regulating hormones
Time frame: 3 hours
Free fatty acids
Time frame: 3 hours
Glycerol
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Raben, Prof principal investigator
Prof at the department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish and carbohydrats with low or high GI and Veal and carbohydrats with low or high GI in people with Overweight, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in diet induced thermogenesis between the four test meals (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.