Deficiency; CalorieNCT02696772
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake
A study testing Energy intake in people with Deficiency; Calorie, run by Loughborough University.
Trial summary
Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficiency; Calorie
- What is being tested?
- Energy intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Sep 2015
- 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
- non-smoker, not currently dieting, weight stable for >6 months (self-reported), no known history of cardiovascular or renal disease.
Who cannot join
- food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (>4 units/day), intensive training schedule (>10 h/week)
About this study
Official title: Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake in Lean Males and Females
Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week. However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined. This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.
- Conditions
- Deficiency; Calorie
- Being tested
- Energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy intakeOther
| Study group | Role | What they receive |
|---|---|---|
| Energy balance | Experimental | Intervention day diet containing 100% of estimated energy requirements Receives: Other: Energy intake |
| Energy restriction | Experimental | Intervention day diet containing 25% of estimated energy requirements Receives: Other: Energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum energy intake
Measured at laboratory-based meals and weight food records
Measured: 48 hours
Subjective appetite
Measured using visual analogue scales
Measured: 48 hours
Plasma acylated Ghrelin
Measured using ELISA from venous blood samples
Measured: 24 hours
Plasma active glugagon-like peptide 1
Measured using ELISA from venous blood samples
Measured: 24 hours
Secondary outcomes (6)
Plasma insulin
Measured using ELISA from venous blood samples
Measured: 24 hours
Plasma glucose
Measured using colorimetric assay from venous blood samples
Measured: 24 hours
Plasma Non-esterified Fatty acids
Measured using colorimetric from venous blood samples
Measured: 24 hours
Energy expenditure
Measured under resting conditions using indirect calorimetry
Measured: 24 hours
Fat oxidation
Measured under resting conditions using indirect calorimetry
Measured: 24 hours
carbohydrate oxidation
Measured under resting conditions using indirect calorimetry
Measured: 24 hors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deficiency; CalorieStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696772
- Sponsor's protocol ID
- R13-P149DC
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clayton DJ, Burrell K, Mynott G, Creese M, Skidmore N, Stensel DJ, James LJ. Effect of 24-h severe energy restriction on appetite regulation and ad libitum energy intake in lean men and women. Am J Clin Nutr. 2016 Dec;104(6):1545-1553. doi: 10.3945/ajcn.116.136937. Epub 2016 Nov 2.
PubMed 27806971
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake in Lean Males and Females
- ClinicalTrials.gov ID
- NCT02696772
- Acronym / sponsor ID
- R13-P149DC
- Conditions
- Deficiency; Calorie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Mar 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.
Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week. However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined. This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy balance | Experimental | Other: Energy intakeIntervention day diet containing 100% of estimated energy requirements |
| Energy restriction | Experimental | Other: Energy intakeIntervention day diet containing 25% of estimated energy requirements |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-smoker, not currently dieting, weight stable for >6 months (self-reported), no known history of cardiovascular or renal disease.
Key exclusion criteria (1 listed)
- food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (>4 units/day), intensive training schedule (>10 h/week)
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 |
|---|---|---|
| Energy intake | Other | Energy balance, Energy restriction |
Primary outcome
Ad-libitum energy intake
Time frame: 48 hours
Measured at laboratory-based meals and weight food records
Subjective appetite
Time frame: 48 hours
Measured using visual analogue scales
Plasma acylated Ghrelin
Time frame: 24 hours
Measured using ELISA from venous blood samples
Plasma active glugagon-like peptide 1
Time frame: 24 hours
Measured using ELISA from venous blood samples
6 secondary outcomes
Plasma insulin
Time frame: 24 hours
Plasma glucose
Time frame: 24 hours
Plasma Non-esterified Fatty acids
Time frame: 24 hours
Energy expenditure
Time frame: 24 hours
Fat oxidation
Time frame: 24 hours
carbohydrate oxidation
Time frame: 24 hors
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 3 Mar 2016.
- Derived from this study: PubMed 27806971Clayton DJ, Burrell K, Mynott G, Creese M, Skidmore N, Stensel DJ, James LJ. Effect of 24-h severe energy restriction on appetite regulation and ad libitum energy intake in lean men and women. Am J Clin Nutr. 2016 Dec;104(6):1545-1553. doi: 10.3945/ajcn.116.136937. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No
Related trials for Deficiency; Calorie
Recruiting
REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
Osteogenesis Imperfecta, Osteoporosis
RecruitingObservational study
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition Pregnancy, Malnutrition in Children
Not yet recruiting
Nutritional Assessment in Patient of Mucopolysaccharide "
Mucopolysaccharidosis (MPS), Malnutrition (Calorie)
Not yet recruiting
Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.
Stroke, Hypoalbuminemia
Recruiting
Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
Parenteral Nutrition, Gastroparesis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Energy intake in people with Deficiency; Calorie, run by Loughborough University.
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 1 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Ad-libitum energy intake (time frame: 48 hours). The study lists 4 primary outcomes in all. 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 NCT02696772, which also lists 1 linked publication.
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 3 Mar 2016.