Abdominal ObesityNCT04894526
Alternating Energy Intake and Blood Fat Content After a Meal
A study testing Alternating Energy Intake and Regular Energy Intake in people with Abdominal Obesity and Postprandial Lipemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Increasing evidence suggests that meal timing affects metabolic health. For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure. However, IF protocols often result in significant weight loss. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism
- What is being tested?
- Alternating Energy Intake and Regular Energy Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2021to Dec 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and women as judged by study physician
- Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
- Aged between 18 - 75 years
- Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
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- Women should be pre- or postmenopausal
- Sedentary (light exercise < 1 h per week) or moderately active (moderate exercise 1-2 h per week)
- Having a general practitioner
- Agreeing that the participant and general practitioner will be informed about medically relevant personal test results by a physician
- Willing to comply to study protocol during study
- Informed consent signed
Who cannot join
- Fasting plasma glucose ≥ 7 mmol/l
- Fasting serum triacylglycerol ≥ 4.5 mmol/l
- Fasting serum total cholesterol ≥ 8 mmol/l
- Blood pressure ≥ 160/100 mm Hg
- Current smoker, or smoking cessation < 12 months
- Drug abuse
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- Alcohol abuse (≥ 21 alcohol consumptions per week)
- Use of medication known to affect blood pressure, serum lipid metabolism, or glucose metabolism
- Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, familiar hypercholesterolemia, liver or bowel disease or diabetes)
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Women who are perimenopausal, have an irregular menstrual cycle, or are pregnant
- Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator), e.g. weight loss medication
- Reported dietary habits: medically prescribed diets or slimming diets
- Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 AM
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
Maite M. Schroor, MSc., +31433884258, maite.schroor@maastrichtuniversity.nl
Ronald P. Mensink, PhD
About this study
Official title: The Effect of Alternating Energy Intake Compared to Regular Energy Intake on the Fat Content in the Blood After a Meal in Abdominally Obese Adults
Increasing evidence suggests that meal timing affects metabolic health. For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure. However, IF protocols often result in significant weight loss. Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss. Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days. Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.
- Being tested
- Alternating Energy Intake, Regular Energy Intake
- Keywords
- Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating Energy IntakeOther
To alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks.
Regular Energy IntakeOther
To consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alternating energy intake schedule | Experimental | To alternate between caloric overconsumption and caloric underconsumption from day-to-day Receives: Other: Alternating Energy Intake |
| Regular energy intake schedule | Active comparator | To consume the usual energy intake on a daily basis Receives: Other: Regular Energy Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglycerol area under the curve (AUC)
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
Measured: 4 hours
Secondary outcomes (10)
Fasting glucose metabolism
Fasting glucose metabolism (includes e.g. glucose and insulin concentrations)
Measured: Baseline, week 2, and twice in week 4
Fasting lipid metabolism
Fasting serum lipid and lipoprotein profile
Measured: Baseline, week 2, and twice in week 4
Marker for postprandial lipid metabolism
Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
Measured: 4 hour period after consumption of a standardised mixed meal
Markers for postprandial glucose metabolism
Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
Measured: 4 hour period after consumption of a standardised mixed meal
24-hour glucose levels
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
Measured: 24 hours
Day-time glucose levels
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
Measured: From 07:00 to 22:00 (15 hours)
Night-time glucose levels
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
Measured: From 22:01 to 06:59 (8 hours and 58 min)
Glucose levels after main meal consumption
The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
Measured: 2 hours
The mean amplitude of glycemic excursions (MAGE)
MAGE as parameter for the assessment of glycemic variability.
Measured: 24 hours
Continuous overall net glycemic action (CONGA)
CONGA to assess intraday glucose variability within predetermined time windows -> 1-hour interval (CONGA-1), 2-hour interval (CONGA-2), and 4-hour interval (CONGA-4).
Measured: 1 hour, 2 hours, and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start14 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894526
- Sponsor's protocol ID
- METC 20-089
- Status last verified
- Aug 2022
- First submitted
- 20 Apr 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alternating Energy Intake Compared to Regular Energy Intake on the Fat Content in the Blood After a Meal in Abdominally Obese Adults
- ClinicalTrials.gov ID
- NCT04894526
- Acronym / sponsor ID
- METC 20-089
- Keywords
- Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 May 2021 (actual)
- 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.
Increasing evidence suggests that meal timing affects metabolic health. For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure. However, IF protocols often result in significant weight loss. Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss. Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days. Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternating energy intake schedule | Experimental | Other: Alternating Energy IntakeTo alternate between caloric overconsumption and caloric underconsumption from day-to-day |
| Regular energy intake schedule | Active comparator | Other: Regular Energy IntakeTo consume the usual energy intake on a daily basis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Apparently healthy men and women as judged by study physician
- Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
- Aged between 18 - 75 years
- Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Key exclusion criteria (15 listed)
- Fasting plasma glucose ≥ 7 mmol/l
- Fasting serum triacylglycerol ≥ 4.5 mmol/l
- Fasting serum total cholesterol ≥ 8 mmol/l
- Blood pressure ≥ 160/100 mm Hg
- Current smoker, or smoking cessation < 12 months
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 |
|---|---|---|
| Alternating Energy IntakeTo alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks. | Other | Alternating energy intake schedule |
| Regular Energy IntakeTo consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks. | Other | Regular energy intake schedule |
Primary outcome
Triacylglycerol area under the curve (AUC)
Time frame: 4 hours
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
10 secondary outcomes
Fasting glucose metabolism
Time frame: Baseline, week 2, and twice in week 4
Fasting lipid metabolism
Time frame: Baseline, week 2, and twice in week 4
Marker for postprandial lipid metabolism
Time frame: 4 hour period after consumption of a standardised mixed meal
Markers for postprandial glucose metabolism
Time frame: 4 hour period after consumption of a standardised mixed meal
24-hour glucose levels
Time frame: 24 hours
Day-time glucose levels
Time frame: From 07:00 to 22:00 (15 hours)
Night-time glucose levels
Time frame: From 22:01 to 06:59 (8 hours and 58 min)
Glucose levels after main meal consumption
Time frame: 2 hours
The mean amplitude of glycemic excursions (MAGE)
Time frame: 24 hours
Continuous overall net glycemic action (CONGA)
Time frame: 1 hour, 2 hours, and 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating Energy Intake and Regular Energy Intake in people with Abdominal Obesity and Postprandial Lipemia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 12 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 Netherlands. 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?
Contact Maite M. Schroor, MSc. (+31433884258, maite.schroor@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triacylglycerol area under the curve (AUC) (time frame: 4 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 26 Aug 2022.