ObesityNCT04735783
Placebo Breakfast Consumption, Appetite and Food Intake
A study testing Typical whole-food breakfast in people with Obesity, run by Nottingham Trent University at 2 sites in United Kingdom.
Trial summary
The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Typical whole-food breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Jan 2020to 11 Dec 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker.
- Habitually consuming breakfast at least 3 days per week.
- Have maintained a stable weight for 6 months (self-reported).
- No known history of gastric, digestive, cardiovascular or renal disease.
Who cannot join
- Food allergies, dislike or intolerance of study foods or drinks.
- Not currently on a weight management program or have irregular eating patterns (i.e. extended fasting periods >8h other than overnight - self reported).
- Use of medication that may affect hormone concentrations.
- Excessive alcohol consumption (>4 units/day).
- Intensive training schedule (>10 hours/week).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Loughborough University
Loughborough, LE11 3TU
Nottingham Trent University
Nottingham, NG11 8NS
About this study
Official title: Effect of the Perception of Breakfast Consumption on Appetite and Energy Intake in Healthy Males
The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Participants will not be told that the placebo breakfast contains nearly no energy until the end of the study. The breakfasts will be provided in a randomised order, with a period of at least four days separating the trials. Blood samples will be taken before and after the breakfast is eaten to see how appetite-regulating proteins and blood sugars respond during the morning. Appetite questionnaires will also be completed throughout the morning, and a pasta-based lunch meal will be provided so that voluntary food intake can be measured.
Read the detailed description
Obesity is a risk factor for several chronic diseases, including type-2 diabetes, heart disease and some forms of cancer. There is clear evidence demonstrating that weight gain occurs progressively over the lifespan, highlighting that preventative action should be taken by young, lean individuals, who may yet develop overweight or obesity later in life. A positive energy imbalance, in which energy intake exceeds energy expenditure for a sustained duration, is known to be the underlying systematic cause of obesity. Therefore, reducing daily energy intake is a seemingly simple solution to the this problem. However, compensatory alterations in appetite regulation which stimulate an increase in energy intake often impede the long-term success of such interventions.
Extending the overnight fasting period, thereby restricting the time available for food intake, has emerged as an effective dietary strategy for reducing daily energy intake and may assist with weight management. Laboratory studies have shown that skipping breakfast typically results in increased appetite during the morning, and an increase in energy intake at lunch. Therefore, the long-term success of skipping breakfast may be reduced by elevated appetite sensations. A recent study which aimed to assess the effects of a very-low energy, placebo breakfast on resistance exercise performance noted that appetite was suppressed after consuming the placebo, despite its lack of energy content. Whether this suppression of appetite following placebo breakfast consumption results in a reduced energy intake at lunch, is currently unknown. Therefore, the investigators are interested to examine the subjective and hormonal appetite responses to placebo breakfast consumption, compared with these responses to an overt breakfast consumption trial an overt breakfast skipping trial, and whether these changes result in any differences in voluntary energy intake at lunch.
The present study is a randomised, controlled, crossover study in which fourteen healthy, habitual breakfast-consuming (self-reported) males will consume a very low-energy, viscous placebo breakfast, a typically consumed, whole-food breakfast, and a water-only control. At least four days will separate trials.
Participants will firstly complete a pre-screening session in which anthropometric data will be collected. This will be used to determine the energy content of the typical whole-food breakfast.
- Conditions
- Obesity
- Being tested
- Placebo breakfast, Typical whole-food breakfast, Water-only control
- Keywords
- Breakfast skipping, Energy intake, Energy balance, Appetite hormones, Placebo feeding
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo breakfastDietary supplement
Participants will consume a very low-energy, placebo breakfast meal, but will be unaware of its near complete absence of energy until the end of the study.
Typical whole-food breakfastDietary supplement
Participants will consume a typical whole-food breakfast meal, equating to 20% of estimated energy requirements.
Water-only controlDietary supplement
Participants will consume a volume of plain water to match the water content of the very low-energy placebo breakfast and the typical whole-food breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Very low-energy, viscous placebo breakfast | Experimental | Participants will consumed a viscous breakfast meal from a standard bowl with a standard spoon. The volume of the meal will be 5 mL/kg body mass, consisting of 15% (0.75 mL/kg body mass) low-energy flavoured squash, with the remainder made up of tap water. To thicken the solution and increase the perception of energy intake, 0.1 g/kg xanthan gum (a soluble fibre often used as a low-energy thickening agent) will be added and the mixture will be blended thoroughly. An additional 3 mL/kg tap water will be consumed as a drink alongside the meal in this trial. Receives: Dietary Supplement: Placebo breakfast |
| Typical, whole-food breakfast | Active comparator | Participants will consume a standardised meal consisting of puffed rice cereal, semi-skimmed milk, white bread, seedless strawberry jam, and apple juice. This meal will provide 20% of estimated energy requirements, determined by multiplying estimated resting metabolic rate by a physical activity level of 1.6. A measured volume of tap water will be consumed alongside this meal, in order to match total water content of the typical whole-food breakfast to the very low-energy, viscous placebo breakfast. Receives: Dietary Supplement: Typical whole-food breakfast |
| Water-only control | Active comparator | Participants will consume 8 mL/kg body mass of plain tap water to match the total water content of the typical whole-food breakfast and the very low-energy, viscous placebo breakfast. Receives: Dietary Supplement: Water-only control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal
A laboratory-based meal consisting of pasta, tomato sauce and olive oil will be provided to participants in excess of expected consumption. Participants will be permitted 20 minutes to eat as much or as little as they desire, until 'comfortably full and satisfied'.
Measured: 195 minutes post-breakfast provision.
Secondary outcomes (4)
Visual Analogue Scale for Subjective Ratings of Appetite
Time-course of subjective ratings of hunger between breakfast provision and one hour after consuming lunch, measured using an appetite visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.
Measured: Baseline, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 195 minutes, 215 minutes, 275 minutes post-breakfast provision.
Acylated ghrelin
Time-course of acylated ghrelin plasma concentrations across experimental trials.
Measured: Baseline, 60 minutes, 180 minutes post-breakfast provision.
Peptide tyrosine-tyrosine (PYY)
Time-course of PYY plasma concentrations across experimental trials.
Measured: Baseline, 60 minutes, 180 minutes post-breakfast provision.
Blood glucose concentration
Time-course of blood glucose concentrations across experimental trials.
Measured: Baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes post-breakfast provision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start28 Jan 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Model description
- The study design is a randomised, controlled, crossover design in which participants undertake three dietary conditions in a randomised order with at least a four day period in between trials.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University
- Responsible party
- Principal investigator, Tommy Slater, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735783
- Sponsor's protocol ID
- TS_Placebo_2019
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Naharudin MN, Adams J, Richardson H, Thomson T, Oxinou C, Marshall C, Clayton DJ, Mears SA, Yusof A, Hulston CJ, James LJ. Viscous placebo and carbohydrate breakfasts similarly decrease appetite and increase resistance exercise performance compared with a control breakfast in trained males. Br J Nutr. 2020 Jul 28;124(2):232-240. doi: 10.1017/S0007114520001002. Epub 2020 Mar 16.
PubMed 32174286Mears SA, Dickinson K, Bergin-Taylor K, Dee R, Kay J, James LJ. Perception of Breakfast Ingestion Enhances High-Intensity Cycling Performance. Int J Sports Physiol Perform. 2018 Apr 1;13(4):504-509. doi: 10.1123/ijspp.2017-0318. Epub 2018 May 14.
PubMed 28952831Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Effect of extended morning fasting upon ad libitum lunch intake and associated metabolic and hormonal responses in obese adults. Int J Obes (Lond). 2016 Feb;40(2):305-11. doi: 10.1038/ijo.2015.154. Epub 2015 Aug 17.
PubMed 26278005Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.
PubMed 26004166Clayton DJ, Barutcu A, Machin C, Stensel DJ, James LJ. Effect of Breakfast Omission on Energy Intake and Evening Exercise Performance. Med Sci Sports Exerc. 2015 Dec;47(12):2645-52. doi: 10.1249/MSS.0000000000000702.
PubMed 25970668Betts JA, Chowdhury EA, Gonzalez JT, Richardson JD, Tsintzas K, Thompson D. Is breakfast the most important meal of the day? Proc Nutr Soc. 2016 Nov;75(4):464-474. doi: 10.1017/S0029665116000318. Epub 2016 Jun 13.
PubMed 27292940Clayton DJ, James LJ. The effect of breakfast on appetite regulation, energy balance and exercise performance. Proc Nutr Soc. 2016 Aug;75(3):319-27. doi: 10.1017/S0029665115004243. Epub 2015 Dec 14.
PubMed 26653842Astbury NM, Taylor MA, Macdonald IA. Breakfast consumption affects appetite, energy intake, and the metabolic and endocrine responses to foods consumed later in the day in male habitual breakfast eaters. J Nutr. 2011 Jul;141(7):1381-9. doi: 10.3945/jn.110.128645. Epub 2011 May 11.
PubMed 21562233Levitsky DA, Pacanowski CR. Effect of skipping breakfast on subsequent energy intake. Physiol Behav. 2013 Jul 2;119:9-16. doi: 10.1016/j.physbeh.2013.05.006. Epub 2013 May 11.
PubMed 23672851Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
PubMed 24898233Slater T, Mode WJA, Hough J, James RM, Sale C, James LJ, Clayton DJ. Effect of the perception of breakfast consumption on subsequent appetite and energy intake in healthy males. Eur J Nutr. 2022 Apr;61(3):1319-1330. doi: 10.1007/s00394-021-02727-5. Epub 2021 Nov 11.
PubMed 34766208
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Perception of Breakfast Consumption on Appetite and Energy Intake in Healthy Males
- ClinicalTrials.gov ID
- NCT04735783
- Acronym / sponsor ID
- TS_Placebo_2019
- Conditions
- Obesity
- Keywords
- Breakfast skipping, Energy intake, Energy balance, Appetite hormones, Placebo feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 3 Feb 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.
The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Participants will not be told that the placebo breakfast contains nearly no energy until the end of the study. The breakfasts will be provided in a randomised order, with a period of at least four days separating the trials. Blood samples will be taken before and after the breakfast is eaten to see how appetite-regulating proteins and blood sugars respond during the morning. Appetite questionnaires will also be completed throughout the morning, and a pasta-based lunch meal will be provided so that voluntary food intake can be measured.
Detailed description
Obesity is a risk factor for several chronic diseases, including type-2 diabetes, heart disease and some forms of cancer. There is clear evidence demonstrating that weight gain occurs progressively over the lifespan, highlighting that preventative action should be taken by young, lean individuals, who may yet develop overweight or obesity later in life. A positive energy imbalance, in which energy intake exceeds energy expenditure for a sustained duration, is known to be the underlying systematic cause of obesity. Therefore, reducing daily energy intake is a seemingly simple solution to the this problem. However, compensatory alterations in appetite regulation which stimulate an increase in energy intake often impede the long-term success of such interventions.
Extending the overnight fasting period, thereby restricting the time available for food intake, has emerged as an effective dietary strategy for reducing daily energy intake and may assist with weight management. Laboratory studies have shown that skipping breakfast typically results in increased appetite during the morning, and an increase in energy intake at lunch. Therefore, the long-term success of skipping breakfast may be reduced by elevated appetite sensations. A recent study which aimed to assess the effects of a very-low energy, placebo breakfast on resistance exercise performance noted that appetite was suppressed after consuming the placebo, despite its lack of energy content. Whether this suppression of appetite following placebo breakfast consumption results in a reduced energy intake at lunch, is currently unknown. Therefore, the investigators are interested to examine the subjective and hormonal appetite responses to placebo breakfast consumption, compared with these responses to an overt breakfast consumption trial an overt breakfast skipping trial, and whether these changes result in any differences in voluntary energy intake at lunch.
The present study is a randomised, controlled, crossover study in which fourteen healthy, habitual breakfast-consuming (self-reported) males will consume a very low-energy, viscous placebo breakfast, a typically consumed, whole-food breakfast, and a water-only control. At least four days will separate trials.
Participants will firstly complete a pre-screening session in which anthropometric data will be collected. This will be used to determine the energy content of the typical whole-food breakfast.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study design is a randomised, controlled, crossover design in which participants undertake three dietary conditions in a randomised order with at least a four day period in between trials.
| Arm | Type | Receives |
|---|---|---|
| Very low-energy, viscous placebo breakfast | Experimental | Dietary Supplement: Placebo breakfastParticipants will consumed a viscous breakfast meal from a standard bowl with a standard spoon. The volume of the meal will be 5 mL/kg body mass, consisting of 15% (0.75 mL/kg body mass) low-energy flavoured squash, with the remainder made up of tap water. To thicken the solution and increase the perception of energy intake, 0.1 g/kg xanthan gum (a soluble fibre often used as a low-energy thickening agent) will be added and the mixture will be blended thoroughly. An additional 3 mL/kg tap water will be consumed as a drink alongside the meal in this trial. |
| Typical, whole-food breakfast | Active comparator | Dietary Supplement: Typical whole-food breakfastParticipants will consume a standardised meal consisting of puffed rice cereal, semi-skimmed milk, white bread, seedless strawberry jam, and apple juice. This meal will provide 20% of estimated energy requirements, determined by multiplying estimated resting metabolic rate by a physical activity level of 1.6. A measured volume of tap water will be consumed alongside this meal, in order to match total water content of the typical whole-food breakfast to the very low-energy, viscous placebo breakfast. |
| Water-only control | Active comparator | Dietary Supplement: Water-only controlParticipants will consume 8 mL/kg body mass of plain tap water to match the total water content of the typical whole-food breakfast and the very low-energy, viscous placebo breakfast. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoker.
- Habitually consuming breakfast at least 3 days per week.
- Have maintained a stable weight for 6 months (self-reported).
- No known history of gastric, digestive, cardiovascular or renal disease.
Key exclusion criteria (5 listed)
- Food allergies, dislike or intolerance of study foods or drinks.
- Not currently on a weight management program or have irregular eating patterns (i.e. extended fasting periods >8h other than overnight - self reported).
- Use of medication that may affect hormone concentrations.
- Excessive alcohol consumption (>4 units/day).
- Intensive training schedule (>10 hours/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 |
|---|---|---|
| Placebo breakfastParticipants will consume a very low-energy, placebo breakfast meal, but will be unaware of its near complete absence of energy until the end of the study. | Dietary supplement | Very low-energy, viscous placebo breakfast |
| Typical whole-food breakfastParticipants will consume a typical whole-food breakfast meal, equating to 20% of estimated energy requirements. | Dietary supplement | Typical, whole-food breakfast |
| Water-only controlParticipants will consume a volume of plain water to match the water content of the very low-energy placebo breakfast and the typical whole-food breakfast. | Dietary supplement | Water-only control |
Primary outcome
Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal
Time frame: 195 minutes post-breakfast provision.
A laboratory-based meal consisting of pasta, tomato sauce and olive oil will be provided to participants in excess of expected consumption. Participants will be permitted 20 minutes to eat as much or as little as they desire, until 'comfortably full and satisfied'.
4 secondary outcomes
Visual Analogue Scale for Subjective Ratings of Appetite
Time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 195 minutes, 215 minutes, 275 minutes post-breakfast provision.
Acylated ghrelin
Time frame: Baseline, 60 minutes, 180 minutes post-breakfast provision.
Peptide tyrosine-tyrosine (PYY)
Time frame: Baseline, 60 minutes, 180 minutes post-breakfast provision.
Blood glucose concentration
Time frame: Baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes post-breakfast provision.
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 Feb 2021.
- Background: PubMed 32174286Naharudin MN, Adams J, Richardson H, Thomson T, Oxinou C, Marshall C, Clayton DJ, Mears SA, Yusof A, Hulston CJ, James LJ. Viscous placebo and carbohydrate breakfasts similarly decrease appetite and increase resistance exercise performance compared with a control breakfast in trained males. Br J Nutr. 2020 Jul 28;124(2):232-240. doi: 10.1017/S0007114520001002. Epub 2020 Mar 16.
- Background: PubMed 28952831Mears SA, Dickinson K, Bergin-Taylor K, Dee R, Kay J, James LJ. Perception of Breakfast Ingestion Enhances High-Intensity Cycling Performance. Int J Sports Physiol Perform. 2018 Apr 1;13(4):504-509. doi: 10.1123/ijspp.2017-0318. Epub 2018 May 14.
- Background: PubMed 26278005Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Effect of extended morning fasting upon ad libitum lunch intake and associated metabolic and hormonal responses in obese adults. Int J Obes (Lond). 2016 Feb;40(2):305-11. doi: 10.1038/ijo.2015.154. Epub 2015 Aug 17.
- Background: PubMed 26004166Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.
- Background: PubMed 25970668Clayton DJ, Barutcu A, Machin C, Stensel DJ, James LJ. Effect of Breakfast Omission on Energy Intake and Evening Exercise Performance. Med Sci Sports Exerc. 2015 Dec;47(12):2645-52. doi: 10.1249/MSS.0000000000000702.
- Background: PubMed 27292940Betts JA, Chowdhury EA, Gonzalez JT, Richardson JD, Tsintzas K, Thompson D. Is breakfast the most important meal of the day? Proc Nutr Soc. 2016 Nov;75(4):464-474. doi: 10.1017/S0029665116000318. Epub 2016 Jun 13.
- Background: PubMed 26653842Clayton DJ, James LJ. The effect of breakfast on appetite regulation, energy balance and exercise performance. Proc Nutr Soc. 2016 Aug;75(3):319-27. doi: 10.1017/S0029665115004243. Epub 2015 Dec 14.
- Background: PubMed 21562233Astbury NM, Taylor MA, Macdonald IA. Breakfast consumption affects appetite, energy intake, and the metabolic and endocrine responses to foods consumed later in the day in male habitual breakfast eaters. J Nutr. 2011 Jul;141(7):1381-9. doi: 10.3945/jn.110.128645. Epub 2011 May 11.
- Background: PubMed 23672851Levitsky DA, Pacanowski CR. Effect of skipping breakfast on subsequent energy intake. Physiol Behav. 2013 Jul 2;119:9-16. doi: 10.1016/j.physbeh.2013.05.006. Epub 2013 May 11.
- Background: PubMed 24898233Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
- Derived from this study: PubMed 34766208Slater T, Mode WJA, Hough J, James RM, Sale C, James LJ, Clayton DJ. Effect of the perception of breakfast consumption on subsequent appetite and energy intake in healthy males. Eur J Nutr. 2022 Apr;61(3):1319-1330. doi: 10.1007/s00394-021-02727-5. Epub 2021 Nov 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Typical whole-food breakfast in people with Obesity, run by Nottingham Trent University at 2 sites 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 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: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal (time frame: 195 minutes post-breakfast provision.). 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 NCT04735783, which also lists 11 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 3 Feb 2021.