Metabolic DisturbanceNCT05569837
The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure and Metabolism
A study testing Regular meal pattern and Irregular meal pattern in people with Metabolic Disturbance and Obesity, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
In this study we will compare the effect of two different meal patterns. Firstly, participants will consume a diet providing their estimated energy requirement for a 7 day standardisation period (6 meals per day). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance, Obesity
- What is being tested?
- Regular meal pattern and Irregular meal pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2021to 30 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 30 kg/m2,
- Age between 18 and 45y,
- Non-smokers,
- Non high-alcohol consumers (≥ 14 units/week),
- Regular menstruation or on the oral contraceptive pills,
- Their weight is stable during the previous 3 months,
- No self-reported history of serious medical conditions and not under medication.
Who cannot join
- Pregnant or lactating women
- Smokers
- High-alcohol consumers (≥ 14 units/week)
- Subjects with high score for depression using Becks Depression Inventory
- subjects Eating Attitudes Test (EAT-26) score >20
- Subjects who on diet or seeking to lose weight
- Subjects with high consumption of coffee or tea > 3 cups/day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure, Metabolism and Circadian Rhythm: a Randomized Controlled Trial
In this study we will compare the effect of two different meal patterns. Firstly, participants will consume a diet providing their estimated energy requirement for a 7 day standardisation period (6 meals per day). After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will randomly follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d). Following a further laboratory visit day, they will then consume the previous standardisation diet for a further 3 days. The energy intake provided will be calculated to provide less energy than subjects are using which may result in approximately 2kg of weight loss. Participants will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. In the laboratory visit, participants will be fasting and for 3 h after intake of a test drink, measurements will be taken of energy expenditure, fasting glucose, fasting gut hormones, fasting lipids and fasting insulin. A test meal will be offered. A questionnaire of subjective appetite ratings will be assessed while fasting, after the test drink, after the test meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken during the whole study period, Core body temperature will be measured before and after the intervention period. Also, wrist temperature will be measured during the whole study period.
Read the detailed description
Experimental protocol:
28 women who are a healthy weight or overweight (aged 18-45 years) will be recruited to a randomized parallel trial to follow one of two 14-d hypo-energetic diets. Firstly, participants will consume a diet providing their estimated energy requirement (6 meals/day) for a 7 day standardisation period. After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d) (energy deficit of 800kcal/ 24h in both diets) (identical foods provided on both interventions whilst otherwise free living). Following a further laboratory visit day, they will then consume the previous standardisation diet providing their estimated energy requirement (6 meals/day) for a further 3 days. All foods to be consumed during the study will be provided to free of charge. These will comprise foods commonly consumed in the British diet and will be consumed in amounts designed to provide 800kcal/24h less than estimated energy requirements in the intervention period. Participants will attend the laboratory visits fasting and a blood sample will be obtained for fasting glucose, insulin and lipids. A test drink will then be given and over the following three hours measurements will be taken of energy expenditure (TEF). An ad libitum pasta test meal will be offered three hours after the test drink has been given. Subjective appetite ratings will be assessed while fasting, after the test drink, after the ad libitum meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken throughout the study. Ambulatory activity pattern measurement will be assessed in the intervention period. Core body temperature will be measured during the last 3 days of the first standardisation period, and during the final three standardisation days. Peripheral body temperature will be measured throughout the study period using a small i- button secured to the wrist. The study will commence at the early phase of the menstrual cycle (days1-7). A constant sleep-wake (and light exposure) routine will be followed for the whole study period which will be assessed by a written questionnaire form
- Conditions
- Metabolic Disturbance, Obesity
- Being tested
- Regular meal pattern, Irregular meal pattern
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular meal patternOther
6 meals every day
Irregular meal patternOther
It consists of consuming a different number of meals every day (between 3 and 9).
| Study group | Role | What they receive |
|---|---|---|
| Regular meal pattern | Experimental | Participants will follow a regular meal pattern for 14 days Receives: Other: Regular meal pattern |
| Irregular meal pattern | Experimental | Participants will follow an irregular meal pattern for 14 days Receives: Other: Irregular meal pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline thermic effect of food in kcal at 2 weeks intervention
Indirect calorimetry (GEM system; Europa Scientific Ltd.) will be used to determine the resting energy expenditure (REE) and thermic effect of food (TEF). REE will be measured in the fasted state for 20 min. The TEF will be measured for periods of 15 min at 30-min intervals during the 3 h after test drink (milkshake) consumption.
Measured: Over 3 hours for 2 days
Secondary outcomes (11)
Change from baseline body Weight in kilograms at 2 weeks intervention
Body weight
Measured: 1 day before intervention and 1 day after intervention
Change in subjective appetite
a booklet will be given to record the subjective appetite (hunger, fullness and desire to eat) using visual analogue scales (VAS) before and after each single meal on:
- The last day of the pre-standardization period,
- The first day of the post-intervention period.
- Pre-lab visit day.
- Post-lab visit day.
- Day 7 during the intervention period.
- Day 14 during intervention period.
Measured: 2 days in lab visit, 1 day pre-intervention standardization period, 1 day post-intervention standardization period and 2 days in intervention period
Continuous interstitial glucose
Continuous interstitial glucose will be undertaken using a continuous glucose monitor (CGM) the FreeStyle Libre System during the whole study period
Measured: 26 days
Change from baseline fasting glucose in mmol/L at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting sample of serum glucose
Measured: 1 day before intervention and 1 day after intervention
Change from baseline fasting insulin in mlU/L at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting sample of serum insulin
Measured: 1 day before intervention and 1 day after intervention
Change from baseline fasting lipids in mmol/L at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting sample of serum total cholesterol, HDL cholesterol, LDL cholesterol and triacylglycerol.
Measured: 1 day before intervention and 1 day after intervention
Change from baseline fasting glucagon-like peptide1 in pM at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting plasma glucagon-like peptide1(GLP-1).
Measured: 1 day before intervention and 1 day after intervention
Change from baseline fasting peptide YY in pg/ml at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting plasma peptide YY (PYY).
Measured: 1 day before intervention and 1 day after intervention
Change from baseline fasting ghrelin in pg/ml at 2 weeks intervention
A fasting blood samples will be taken, just before ingestion of the test drink to assess the mean of the fasting plasma ghrelin.
Measured: 1 day before intervention and 1 day after intervention
Change from baseline core body temperature in Celsius at 2 weeks intervention
Core temperature will be assessed using an ingestible telemetry pill and associated monitor (e-Celsius Performance pill and monitor e-Celcius™ BodyCap).
Measured: 3 days in pre and post intervention
Peripheral wrist temperature in Celsius
Wrist temperature will be assessed through a wireless iButton data logger
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start15 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisturbanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moira Taylor, University of Nottingham
- Investigators
- Moira Taylor, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569837
- Sponsor's protocol ID
- 473- 2001
- Status last verified
- Nov 2022
- First submitted
- 21 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- 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
Publications
Alhussain MH, Macdonald IA, Taylor MA. Irregular meal-pattern effects on energy expenditure, metabolism, and appetite regulation: a randomized controlled trial in healthy normal-weight women. Am J Clin Nutr. 2016 Jul;104(1):21-32. doi: 10.3945/ajcn.115.125401. Epub 2016 Jun 15.
PubMed 27305952Farshchi HR, Taylor MA, Macdonald IA. Regular meal frequency creates more appropriate insulin sensitivity and lipid profiles compared with irregular meal frequency in healthy lean women. Eur J Clin Nutr. 2004 Jul;58(7):1071-7. doi: 10.1038/sj.ejcn.1601935.
PubMed 15220950Farshchi HR, Taylor MA, Macdonald IA. Decreased thermic effect of food after an irregular compared with a regular meal pattern in healthy lean women. Int J Obes Relat Metab Disord. 2004 May;28(5):653-60. doi: 10.1038/sj.ijo.0802616.
PubMed 15085170Farshchi HR, Taylor MA, Macdonald IA. Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women. Am J Clin Nutr. 2005 Jan;81(1):16-24. doi: 10.1093/ajcn/81.1.16.
PubMed 15640455
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure, Metabolism and Circadian Rhythm: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05569837
- Acronym / sponsor ID
- 473- 2001
- Conditions
- Metabolic Disturbance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Oct 2022 (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.
In this study we will compare the effect of two different meal patterns. Firstly, participants will consume a diet providing their estimated energy requirement for a 7 day standardisation period (6 meals per day). After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will randomly follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d). Following a further laboratory visit day, they will then consume the previous standardisation diet for a further 3 days. The energy intake provided will be calculated to provide less energy than subjects are using which may result in approximately 2kg of weight loss. Participants will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. In the laboratory visit, participants will be fasting and for 3 h after intake of a test drink, measurements will be taken of energy expenditure, fasting glucose, fasting gut hormones, fasting lipids and fasting insulin. A test meal will be offered. A questionnaire of subjective appetite ratings will be assessed while fasting, after the test drink, after the test meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken during the whole study period, Core body temperature will be measured before and after the intervention period. Also, wrist temperature will be measured during the whole study period.
Detailed description
Experimental protocol:
28 women who are a healthy weight or overweight (aged 18-45 years) will be recruited to a randomized parallel trial to follow one of two 14-d hypo-energetic diets. Firstly, participants will consume a diet providing their estimated energy requirement (6 meals/day) for a 7 day standardisation period. After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d) (energy deficit of 800kcal/ 24h in both diets) (identical foods provided on both interventions whilst otherwise free living). Following a further laboratory visit day, they will then consume the previous standardisation diet providing their estimated energy requirement (6 meals/day) for a further 3 days. All foods to be consumed during the study will be provided to free of charge. These will comprise foods commonly consumed in the British diet and will be consumed in amounts designed to provide 800kcal/24h less than estimated energy requirements in the intervention period. Participants will attend the laboratory visits fasting and a blood sample will be obtained for fasting glucose, insulin and lipids. A test drink will then be given and over the following three hours measurements will be taken of energy expenditure (TEF). An ad libitum pasta test meal will be offered three hours after the test drink has been given. Subjective appetite ratings will be assessed while fasting, after the test drink, after the ad libitum meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken throughout the study. Ambulatory activity pattern measurement will be assessed in the intervention period. Core body temperature will be measured during the last 3 days of the first standardisation period, and during the final three standardisation days. Peripheral body temperature will be measured throughout the study period using a small i- button secured to the wrist. The study will commence at the early phase of the menstrual cycle (days1-7). A constant sleep-wake (and light exposure) routine will be followed for the whole study period which will be assessed by a written questionnaire form
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular meal pattern | Experimental | Other: Regular meal patternParticipants will follow a regular meal pattern for 14 days |
| Irregular meal pattern | Experimental | Other: Irregular meal patternParticipants will follow an irregular meal pattern for 14 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI between 18.5 and 30 kg/m2,
- Age between 18 and 45y,
- Non-smokers,
- Non high-alcohol consumers (≥ 14 units/week),
- Regular menstruation or on the oral contraceptive pills,
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Smokers
- High-alcohol consumers (≥ 14 units/week)
- Subjects with high score for depression using Becks Depression Inventory
- subjects Eating Attitudes Test (EAT-26) score >20
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 |
|---|---|---|
| Regular meal pattern6 meals every day | Other | Regular meal pattern |
| Irregular meal patternIt consists of consuming a different number of meals every day (between 3 and 9). | Other | Irregular meal pattern |
Primary outcome
Change from baseline thermic effect of food in kcal at 2 weeks intervention
Time frame: Over 3 hours for 2 days
Indirect calorimetry (GEM system; Europa Scientific Ltd.) will be used to determine the resting energy expenditure (REE) and thermic effect of food (TEF). REE will be measured in the fasted state for 20 min. The TEF will be measured for periods of 15 min at 30-min intervals during the 3 h after test drink (milkshake) consumption.
11 secondary outcomes
Change from baseline body Weight in kilograms at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change in subjective appetite
Time frame: 2 days in lab visit, 1 day pre-intervention standardization period, 1 day post-intervention standardization period and 2 days in intervention period
Continuous interstitial glucose
Time frame: 26 days
Change from baseline fasting glucose in mmol/L at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline fasting insulin in mlU/L at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline fasting lipids in mmol/L at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline fasting glucagon-like peptide1 in pM at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline fasting peptide YY in pg/ml at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline fasting ghrelin in pg/ml at 2 weeks intervention
Time frame: 1 day before intervention and 1 day after intervention
Change from baseline core body temperature in Celsius at 2 weeks intervention
Time frame: 3 days in pre and post intervention
Peripheral wrist temperature in Celsius
Time frame: 26 days
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 2 Nov 2022.
- Background: PubMed 27305952Alhussain MH, Macdonald IA, Taylor MA. Irregular meal-pattern effects on energy expenditure, metabolism, and appetite regulation: a randomized controlled trial in healthy normal-weight women. Am J Clin Nutr. 2016 Jul;104(1):21-32. doi: 10.3945/ajcn.115.125401. Epub 2016 Jun 15.
- Background: PubMed 15220950Farshchi HR, Taylor MA, Macdonald IA. Regular meal frequency creates more appropriate insulin sensitivity and lipid profiles compared with irregular meal frequency in healthy lean women. Eur J Clin Nutr. 2004 Jul;58(7):1071-7. doi: 10.1038/sj.ejcn.1601935.
- Background: PubMed 15085170Farshchi HR, Taylor MA, Macdonald IA. Decreased thermic effect of food after an irregular compared with a regular meal pattern in healthy lean women. Int J Obes Relat Metab Disord. 2004 May;28(5):653-60. doi: 10.1038/sj.ijo.0802616.
- Background: PubMed 15640455Farshchi HR, Taylor MA, Macdonald IA. Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women. Am J Clin Nutr. 2005 Jan;81(1):16-24. doi: 10.1093/ajcn/81.1.16.
- 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.
Moira Taylor, PhD principal investigator
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 Regular meal pattern and Irregular meal pattern in people with Metabolic Disturbance and Obesity, 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 7 inclusion and 7 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 2 Nov 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 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?
Change from baseline thermic effect of food in kcal at 2 weeks intervention (time frame: Over 3 hours for 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569837, which also lists 4 linked publications.
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 2 Nov 2022.