Weight LossNCT04138160
Effects of Two Weeks of 5:2 Intermittent Energy Restriction on Basal and Postprandial Metabolism
A study testing 5:2 Intermittent energy restriction and Continuous energy restriction in people with Weight Loss, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Worldwide, a third of adults were overweight in 2016, and 13% were obese. Excess energy intake results in weight gain. Excess fat increases the risk of disease (eg. cardiovascular diseases, type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, dementia, certain cancers). Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- 5:2 Intermittent energy restriction and Continuous energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2018to 22 May 2019
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages between 20 - 35 years;
- healthy with a body mass index (BMI) between 20 and 27 kg·m-2;
- a waist circumference < 94 cm for males and < 80 cm for females;
- ability to give informed consent
Who cannot join
- smoking (including vaping);
- regularly skipping breakfast;
- any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure;
- clinically significant abnormalities on screening including ECG abnormalities;
- taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension);
- taking medication for diabetes or having diabetes;
Show all 13Show fewer
- a history of substance abuse in the last six months;
- well-trained individuals with PAL>2.00;
- on an energy-restricted diet;
- high alcohol consumption (<3-4 units/d for men; <2-3 units/d for women);
- females who are pregnant or lactating and with irregular menstrual cycles;
- self-reported allergy, intolerance or strong dislike of foods or drinks to be offered for the test breakfast, pasta meal or during the intervention period;
- Beck Depression Inventory (BDI) score >10, and Eating Attitudes Test (EAT-26) score >20 as self-reported markers of symptoms and concerns characteristic of depression and eating disorders, respectively.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Select State..., NG7 2UH
About this study
Official title: Investigating the Effects of Two Weeks of 5:2 Intermittent Energy Restriction or Continuous Energy Restriction on Basal and Postprandial Metabolism in Normal-weight, Young Participants
Worldwide, a third of adults were overweight in 2016, and 13% were obese. Excess energy intake results in weight gain. Excess fat increases the risk of disease (eg. cardiovascular diseases, type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, dementia, certain cancers). Modest weight reduction (>5% of body weight) decreases the incidence and progression of many of these diseases. Daily energy restriction or continuous energy restriction (CER) involves diets that have a 500-600 kcal deficit per day resulting in sustainable weight loss. However, adherence is difficult. Diets following a 5:2 intermittent energy restriction (5:2 IER) pattern may be better. Approximately 75% energy restriction is maintained for 2 non-consecutive days/week and normal energy intake is consumed on the remaining 5 days of the week. Significantly reduced fasting insulin concentration and insulin resistance were shown in the 5:2 IER regimen compared with the CER regimen. In this study, normal-weight young participants will be recruited and 5:2 IER and CER will be compared over 2 week periods. Subcutaneous continuous glucose monitoring (CGM) devices will be undertaken. An ad libitum pasta meal will be consumed by participants three hours after the ingestion of breakfast to evaluate the energy intake. Postprandial thermogenesis in response to the test drink will be evaluated.
Read the detailed description
Once participants have consented to be screened, they will come to the lab for a medical screening. If the medical screening is satisfactory, all participants will be asked to undergo a one-week pre-study standardization period. Participants will be asked to maintain their normal dietary and physical activity patterns throughout this period. Participants will be asked to complete a 3-day food diary, which will be analyzed to evaluate their habitual food intake and temporal distribution of energy intake throughout the day. In addition, participants will be provided with and instructed on how to use, an Actiheart (a device that combines accelerometry with heart rate monitoring). This device will be placed on the participants' chest using two standard electrocardiogram (ECG) electrodes to record HR, heart rate variability and activity level (to allow estimation of total energy expenditure) for one week. Both items will be returned before the next visit, which will be the pre-intervention measurement. After the pre-intervention visit, participants will be then randomly assigned to two weeks of either (1) the CER of 20% restriction below their estimated requirement (~1600 kcal) 7 days/week or (2) the 5:2 IER of 70% restriction (~600 kcal) delivered for two non-consecutive days/week and no restriction (so sufficient energy to meet their requirement) on the other 5 days/week. Seven days after the pre-intervention visit, participants will then start their 2-week intervention. A 7-day gap is designed in a bid to ensure both pre- and post-intervention measurements will be conducted during the second week of the follicular phase for females. The foods, drinks and overall energy restriction will be the same on each arm. Using estimated BMR based on the Henry equation and the individual daily physical activity level (PAL), estimated from the Actiheart during a one-week standardization period and the physical activity questionnaire, allowed the estimation of daily energy requirements for each subject using basal metabolic rate x PAL. Thus energy intake will be tailored to each participant's specific energy requirements. According to the suggestion from The Association of UK Dietitians, 2 non-consecutive ER days can be achieved on Day 1 and Day 4 of an IER week, thus the investigators will fix and prescribed the two ER days in a week with 3 days apart.
Food on intervention days will be prepared based on a 3-day sequence of menus to avoid boredom but be practical regarding the provision of foods. Each menu provides three meals/day to avoid confounding effects causing by altering meal frequency between the interventions. Three meals/day (and no snacks) is selected to make each eating incident acceptable on the most restricted day. Three meals with a macronutrient distribution of ~50% energy from carbohydrates, ~31% from fat and ~19% from protein will be prescribed. The distribution of energy across the day will be 25% of daily energy requirements from breakfast, 37.5% from lunch and 37.5% from the evening meal. To avoid confounding by altering the mealtime, and the period between which meals are consumed, breakfast will be instructed to be consumed between 8 am-8:30 am; lunch between 1 pm-1:30 pm and evening meal between 6 pm-6.30 pm. Menu designed so that it could be proportionally increased and decreased depending on the intervention requirement and informed by cooking facilities available and optimizing food safety. Participants will be instructed to adhere to the prescribed meal plan and record their food intake by taking photos.
On Day 7 of each experimental trial, participants will report to the unit in the morning after an overnight fast (~12h) for the assessment of body weight. The investigators will also use this visit to attach a subcutaneous continuous glucose monitoring (CGM) device, which will be placed on the abdomen to allow for the estimation of continuous blood glucose over the last 7 days of each trial. Also, the investigators will download the data from the pedometer and use it to assess compliance with the requirements of the study during the first week. CGM and pedometer will be removed upon arrival on the post-intervention visit.
On the day after one week pre-study standardization period and the day after the 2-week intervention, the participants will be asked to attend the laboratory after an overnight fast to undergo a series of appetite and metabolic measurements in response to a standardised breakfast in the form of a milk-based test drink (in a volume of 10 kcal/kg body weight and energy distribution from the macronutrients will be 47.9 % carbohydrate, 35.1% fat, and 17% protein) and a subsequent ad libitum pasta lunch containing cheese, olive oil, and tomato sauce, which will provide 148.24 kcal/100g with 49.8%, 15.4% and 34.8% energy provided by carbohydrates, protein and fat, respectively.
- Conditions
- Weight Loss
- Being tested
- 5:2 Intermittent energy restriction, Continuous energy restriction
- Keywords
- obesity dietary restriction
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5:2 Intermittent energy restrictionOther
Also called 5:2 IER
Substantial (70%) energy restriction for 2 non-consecutive days/week interspersed with normal energy intake (isoenergetic) on the remaining 5 days of the week.
Continuous energy restrictionOther
Also called CER
20% energy restriction each day relative to the energy requirement.
| Study group | Role | What they receive |
|---|---|---|
| 5:2 intermittent energy restriction | Experimental | The 5:2 intermittent energy restriction (IER) of 70% restriction (~600 kcal) delivered for two non-consecutive days/week and no restriction (so sufficient energy to meet the requirement of participants) on the other 5 days/week. Receives: Other: 5:2 Intermittent energy restriction |
| Continuous energy restriction | Other | The continuous energy restriction (CER) of 20% restriction below the estimated requirement of participants (~1600 kcal) 7 days/week. Receives: Other: Continuous energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve for insulin
Incremental area under the curve for serum insulin will be calculated using samples at 20 minute intervals between baseline and three hours.
Measured: Over three hours from baseline
Secondary outcomes (6)
Incremental area under the curve for arterialised whole blood glucose
Incremental area under the curve for arterialised whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours.
Measured: Over four hours post baseline
Incremental area under the curve for composite appetite score
Composite appetite score will be calculated using 100mm visual analogue score ratings of satiety, fullness, hunger and prospective food consumption collected very 20 minutes between baseline and four hours.
Measured: Over four hour from baseline
Weight of consumption of a pasta meal three hours after baseline
Weight of pasta consumed from a bowl refilled prior to being empty until participants feel comfortably full.
Measured: Three hours post baseline
Incremental area under the curve for free fatty acid
Incremental area under the curve for FFA will be calculated using samples at 20 minute intervals between baseline and three hours.
Measured: Over three hours from baseline
Incremental area under the curve for TAG
Incremental area under the curve for TAG will be calculated using samples at 20 minute
Measured: Over three hours from baseline
Continuous glucose monitoring
Average glucose of 6 days
Measured: Over last 6 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start18 Oct 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Macdonald, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138160
- Sponsor's protocol ID
- 121-1809
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Two Weeks of 5:2 Intermittent Energy Restriction or Continuous Energy Restriction on Basal and Postprandial Metabolism in Normal-weight, Young Participants
- ClinicalTrials.gov ID
- NCT04138160
- Acronym / sponsor ID
- 121-1809
- Conditions
- Weight Loss
- Keywords
- obesity dietary restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 24 Oct 2019 (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.
Worldwide, a third of adults were overweight in 2016, and 13% were obese. Excess energy intake results in weight gain. Excess fat increases the risk of disease (eg. cardiovascular diseases, type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, dementia, certain cancers). Modest weight reduction (>5% of body weight) decreases the incidence and progression of many of these diseases. Daily energy restriction or continuous energy restriction (CER) involves diets that have a 500-600 kcal deficit per day resulting in sustainable weight loss. However, adherence is difficult. Diets following a 5:2 intermittent energy restriction (5:2 IER) pattern may be better. Approximately 75% energy restriction is maintained for 2 non-consecutive days/week and normal energy intake is consumed on the remaining 5 days of the week. Significantly reduced fasting insulin concentration and insulin resistance were shown in the 5:2 IER regimen compared with the CER regimen. In this study, normal-weight young participants will be recruited and 5:2 IER and CER will be compared over 2 week periods. Subcutaneous continuous glucose monitoring (CGM) devices will be undertaken. An ad libitum pasta meal will be consumed by participants three hours after the ingestion of breakfast to evaluate the energy intake. Postprandial thermogenesis in response to the test drink will be evaluated.
Detailed description
Once participants have consented to be screened, they will come to the lab for a medical screening. If the medical screening is satisfactory, all participants will be asked to undergo a one-week pre-study standardization period. Participants will be asked to maintain their normal dietary and physical activity patterns throughout this period. Participants will be asked to complete a 3-day food diary, which will be analyzed to evaluate their habitual food intake and temporal distribution of energy intake throughout the day. In addition, participants will be provided with and instructed on how to use, an Actiheart (a device that combines accelerometry with heart rate monitoring). This device will be placed on the participants' chest using two standard electrocardiogram (ECG) electrodes to record HR, heart rate variability and activity level (to allow estimation of total energy expenditure) for one week. Both items will be returned before the next visit, which will be the pre-intervention measurement. After the pre-intervention visit, participants will be then randomly assigned to two weeks of either (1) the CER of 20% restriction below their estimated requirement (~1600 kcal) 7 days/week or (2) the 5:2 IER of 70% restriction (~600 kcal) delivered for two non-consecutive days/week and no restriction (so sufficient energy to meet their requirement) on the other 5 days/week. Seven days after the pre-intervention visit, participants will then start their 2-week intervention. A 7-day gap is designed in a bid to ensure both pre- and post-intervention measurements will be conducted during the second week of the follicular phase for females. The foods, drinks and overall energy restriction will be the same on each arm. Using estimated BMR based on the Henry equation and the individual daily physical activity level (PAL), estimated from the Actiheart during a one-week standardization period and the physical activity questionnaire, allowed the estimation of daily energy requirements for each subject using basal metabolic rate x PAL. Thus energy intake will be tailored to each participant's specific energy requirements. According to the suggestion from The Association of UK Dietitians, 2 non-consecutive ER days can be achieved on Day 1 and Day 4 of an IER week, thus the investigators will fix and prescribed the two ER days in a week with 3 days apart.
Food on intervention days will be prepared based on a 3-day sequence of menus to avoid boredom but be practical regarding the provision of foods. Each menu provides three meals/day to avoid confounding effects causing by altering meal frequency between the interventions. Three meals/day (and no snacks) is selected to make each eating incident acceptable on the most restricted day. Three meals with a macronutrient distribution of ~50% energy from carbohydrates, ~31% from fat and ~19% from protein will be prescribed. The distribution of energy across the day will be 25% of daily energy requirements from breakfast, 37.5% from lunch and 37.5% from the evening meal. To avoid confounding by altering the mealtime, and the period between which meals are consumed, breakfast will be instructed to be consumed between 8 am-8:30 am; lunch between 1 pm-1:30 pm and evening meal between 6 pm-6.30 pm. Menu designed so that it could be proportionally increased and decreased depending on the intervention requirement and informed by cooking facilities available and optimizing food safety. Participants will be instructed to adhere to the prescribed meal plan and record their food intake by taking photos.
On Day 7 of each experimental trial, participants will report to the unit in the morning after an overnight fast (~12h) for the assessment of body weight. The investigators will also use this visit to attach a subcutaneous continuous glucose monitoring (CGM) device, which will be placed on the abdomen to allow for the estimation of continuous blood glucose over the last 7 days of each trial. Also, the investigators will download the data from the pedometer and use it to assess compliance with the requirements of the study during the first week. CGM and pedometer will be removed upon arrival on the post-intervention visit.
On the day after one week pre-study standardization period and the day after the 2-week intervention, the participants will be asked to attend the laboratory after an overnight fast to undergo a series of appetite and metabolic measurements in response to a standardised breakfast in the form of a milk-based test drink (in a volume of 10 kcal/kg body weight and energy distribution from the macronutrients will be 47.9 % carbohydrate, 35.1% fat, and 17% protein) and a subsequent ad libitum pasta lunch containing cheese, olive oil, and tomato sauce, which will provide 148.24 kcal/100g with 49.8%, 15.4% and 34.8% energy provided by carbohydrates, protein and fat, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5:2 intermittent energy restriction | Experimental | Other: 5:2 Intermittent energy restrictionThe 5:2 intermittent energy restriction (IER) of 70% restriction (~600 kcal) delivered for two non-consecutive days/week and no restriction (so sufficient energy to meet the requirement of participants) on the other 5 days/week. |
| Continuous energy restriction | Other | Other: Continuous energy restrictionThe continuous energy restriction (CER) of 20% restriction below the estimated requirement of participants (~1600 kcal) 7 days/week. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ages between 20 - 35 years;
- healthy with a body mass index (BMI) between 20 and 27 kg·m-2;
- a waist circumference < 94 cm for males and < 80 cm for females;
- ability to give informed consent
Key exclusion criteria (13 listed)
- smoking (including vaping);
- regularly skipping breakfast;
- any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure;
- clinically significant abnormalities on screening including ECG abnormalities;
- taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension);
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 |
|---|---|---|
| 5:2 Intermittent energy restrictionAlso: 5:2 IERSubstantial (70%) energy restriction for 2 non-consecutive days/week interspersed with normal energy intake (isoenergetic) on the remaining 5 days of the week. | Other | 5:2 intermittent energy restriction |
| Continuous energy restrictionAlso: CER20% energy restriction each day relative to the energy requirement. | Other | Continuous energy restriction |
Primary outcome
Incremental area under the curve for insulin
Time frame: Over three hours from baseline
Incremental area under the curve for serum insulin will be calculated using samples at 20 minute intervals between baseline and three hours.
6 secondary outcomes
Incremental area under the curve for arterialised whole blood glucose
Time frame: Over four hours post baseline
Incremental area under the curve for composite appetite score
Time frame: Over four hour from baseline
Weight of consumption of a pasta meal three hours after baseline
Time frame: Three hours post baseline
Incremental area under the curve for free fatty acid
Time frame: Over three hours from baseline
Incremental area under the curve for TAG
Time frame: Over three hours from baseline
Continuous glucose monitoring
Time frame: Over last 6 days of intervention
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 21 Nov 2019.
- Individual participant dataSharing planned: Yes. Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
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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.
Ian Macdonald, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5:2 Intermittent energy restriction and Continuous energy restriction in people with Weight Loss, run by University of Nottingham at 1 site in United Kingdom.
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 4 inclusion and 13 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 21 Nov 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 United Kingdom. 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?
Incremental area under the curve for insulin (time frame: Over three hours from baseline). 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 21 Nov 2019.