Metabolic RateDIT2NCT02622490
Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food
A study testing two test meals with two different macronutrient compositions in people with Metabolic Rate and Plasma Glucose, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Rate, Plasma Glucose, Serum Insulin
- What is being tested?
- two test meals with two different macronutrient compositions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to May 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants > 18 years with or without obesity
Who cannot join
- Major illnesses,
- thyroid diseases,
- need to take prednisolone,
- psychiatric disease,
- inability to understand Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet-induced Thermogenesis 2
About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.
Read the detailed description
Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.
- Being tested
- two test meals with two different macronutrient compositions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two test meals with two different macronutrient compositionsOther
Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm
| Study group | Role | What they receive |
|---|---|---|
| Low carb. one meal | Active comparator | Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates Receives: Other: two test meals with two different macronutrient compositions |
| Low Carb. 5 small meals | Active comparator | Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates. Receives: Other: two test meals with two different macronutrient compositions |
| High carb. one meal | Active comparator | Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates Receives: Other: two test meals with two different macronutrient compositions |
| High carb. 5 meals | Experimental | Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates. Receives: Other: two test meals with two different macronutrient compositions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic rate
The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours
Measured: During about 3 hours
Secondary outcomes (1)
Effects on glucose and insulin
Repeated test of glucose and insulin for three hours after test meal
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 posted4 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic RateStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
- Investigators
- Fredrik H Nystrom, MD professor, Principal investigator, Faculty of Medicine and Health Science, Linköping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622490
- Sponsor's protocol ID
- DIT2
- Acronym
- DIT2
- Status last verified
- Apr 2019
- First submitted
- 30 Nov 2015
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-induced Thermogenesis 2
- ClinicalTrials.gov ID
- NCT02622490
- Acronym / sponsor ID
- DIT2 / DIT2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 4 Dec 2015 (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.
About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.
Detailed description
Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low carb. one meal | Active comparator | Other: two test meals with two different macronutrient compositionsIntervention: One meal of 750 kcal with 20 % of energy content from carbohydrates |
| Low Carb. 5 small meals | Active comparator | Other: two test meals with two different macronutrient compositionsIntervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates. |
| High carb. one meal | Active comparator | Other: two test meals with two different macronutrient compositionsIntervention: One meal of 750 kcal with 50 % of energy content from carbohydrates |
| High carb. 5 meals | Experimental | Other: two test meals with two different macronutrient compositionsIntervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy participants > 18 years with or without obesity
Key exclusion criteria (5 listed)
- Major illnesses,
- thyroid diseases,
- need to take prednisolone,
- psychiatric disease,
- inability to understand Swedish
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 |
|---|---|---|
| two test meals with two different macronutrient compositionsEither a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm | Other | High carb. 5 meals, High carb. one meal, Low Carb. 5 small meals, Low carb. one meal |
Primary outcome
Metabolic rate
Time frame: During about 3 hours
The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours
1 secondary outcome
Effects on glucose and insulin
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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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.
Fredrik H Nystrom, MD professor principal investigator
Faculty of Medicine and Health Science, Linköping University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two test meals with two different macronutrient compositions in people with Metabolic Rate and Plasma Glucose, run by University Hospital, Linkoeping at 1 site in Sweden.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2019. 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 Sweden. 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?
Results are not available in the source record.
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?
Metabolic rate (time frame: During about 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 24 Apr 2019.