Nutrition and Energy BalanceNCT03509610
Acute Responses to Dietary Carbohydrate Manipulation
A study testing Diet in people with Nutrition and Energy Balance, run by University of Bath at 1 site in United Kingdom.
Trial summary
Sugar is perceived negatively, leading to government taxation and targets to reduce consumption. These actions have been taken based on the limited evidence that high-sugar diets are associated with greater total energy intake. However, energy intake comprises just one half of the energy balance equation (e.g. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition and Energy Balance
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2017to 21 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
Who cannot join
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: The Acute Responses to Manipulating Dietary Carbohydrate Content and Type on All Major Aspects of Energy Balance
Sugar is perceived negatively, leading to government taxation and targets to reduce consumption. These actions have been taken based on the limited evidence that high-sugar diets are associated with greater total energy intake. However, energy intake comprises just one half of the energy balance equation (e.g. balance = intake - expenditure). Without considering energy expenditure, it is impossible to understand the effects of sugar on health. Sugar, and perhaps total carbohydrate intake, may be important for energy balance - perhaps by stimulating increased energy expenditure.
Understanding dietary regulators of energy balance is more important than ever before, because diseases like obesity are a consequence of energy surplus (i.e. energy intake > energy expenditure). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the acute (e.g. 24-hour) responses to manipulating dietary carbohydrate and sugar content on energy balance and health.
Read more
This research will contribute to enabling individuals to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults will be recruited to a randomised crossover study. Measures of energy intake, energy expenditure, metabolic health, appetite, food preference, and gut microbiota will be taken. All laboratory trials will take place at the University of Bath.
Three diets will be investigated:
- Control - reflecting the composition of a typical European diet
- Low sugar - the same composition of a typical European diet but with <5% energy intake from sugar
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
The study will consist of a 3-day lead-in period with the control diet followed by one trial day with each diet.
Read the detailed description
Dietary sugar is increasingly perceived in a negative way. This has led to taxation by government and guidelines by global public health bodies to reduce sugar intake to <5% of energy intake. All available public health guidelines regarding sugar advocate a reduction in sugar intake, despite a lack of evidence to support these recommendations. These guidelines focus on the association between sugar intake and energy intake, without regard for energy expenditure. This oversimplifies situations in which energy surplus is pathological, for example in diseases like obesity. This complexity is demonstrated by evidence that dietary sugar intake is decreasing in the United Kingdom, whilst rates of obesity have increased in the same timeframe.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Carbohydrate availability dictates the capacity to perform physical work. However, the role of carbohydrate in regulating physical activity behaviours has only recently been considered. Ingestion of a carbohydrate-rich breakfast causes a significant increase in 24-hour PAEE compared with no breakfast consumption before midday. The magnitude of this difference is greatest prior to midday, near to when carbohydrate had been ingested and when glucose uptake to peripheral tissue is increased. This points towards a stimulatory role of carbohydrate or sugar on PAEE when carbohydrate is readily available to peripheral tissue. The amount of carbohydrate present in skeletal muscle is dictated by the amount of carbohydrate in the diet. As physical activity is performed by skeletal muscle, dietary carbohydrate intake may regulate physical activity behaviour. Consequently, reducing total carbohydrate intake may result in reduced PAEE.
Studies in which carbohydrate has been manipulated and physical activity has been measured have not been sufficient in answering this research question. Often self-report measures of physical activity are used, which are not sensitive enough to discern meaningful differences. Studies which have measured physical activity objectively, i.e. using pedometers or accelerometers, are confounded by a lack of information about actual carbohydrate intake or concurrent prescription of exercise interventions. Furthermore, government targets of reduced sugar intake to <5% of total energy intake are not aimed at overall carbohydrate intake per se. In the breakfast study mentioned, sugar intake was significantly greater amongst individuals who ate breakfast compared with individuals who fasted until midday. Therefore, it is also plausible that a regulatory role of carbohydrate on PAEE may be due to the type of carbohydrate rather than the absolute amount.
If the availability of carbohydrate to peripheral tissue plays a regulatory role on PAEE, then theoretically the effects of manipulating the amount or type of carbohydrate will be detectable acutely, within 24 hours.
- Conditions
- Nutrition and Energy Balance
- Being tested
- Diet
- Keywords
- Nutrition, Carbohydrates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Receives: Other: Diet |
| LOW SUG | Experimental | Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat Receives: Other: Diet |
| LOW CHO | Experimental | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour physical activity energy expenditure (kcal/day)
24-hour physical activity energy expenditure (kcal/day)
Measured: 24 hours
Secondary outcomes (27)
24-hour energy intake (kcal/day)
24-hour energy intake (kcal/day)
Measured: 24 hours
Fasting glucose concentrations
Fasting glucose concentrations in serum samples
Measured: 24 hours
Postprandial glucose concentrations
Postprandial glucose concentrations in serum samples
Measured: 24 hours
Fasting insulin concentrations
Fasting insulin concentrations in serum samples
Measured: 24 hours
Postprandial insulin concentrations
Postprandial insulin concentrations in serum samples
Measured: 24 hours
Fasting triglyceride concentrations
Fasting and postprandial triglyceride concentrations determined in plasma samples
Measured: 24 hours
Postprandial triglyceride concentrations
Postprandial triglyceride concentrations in serum samples
Measured: 24 hours
Fasting non-esterified fatty acid concentrations
Fasting non-esterified fatty acid concentrations in serum samples
Measured: 24 hours
Postprandial non-esterified fatty acid concentrations
Postprandial non-esterified fatty acid concentrations in serum samples
Measured: 24 hours
Fasting beta-hydroxybutyrate concentrations
Fasting beta-hydroxybutyrate concentrations in serum samples
Measured: 24 hours
Postprandial beta-hydroxybutyrate concentrations
Postprandial beta-hydroxybutyrate concentrations in serum samples
Measured: 24 hours
Subjective appetite
Measured by 0-100 mm visual analogue scale
Measured: 24 hours
Food preference ratings
Food preference ratings determined by bespoke computer software
Measured: 24 hours
Resting substrate oxidation
Resting substrate oxidation determined by indirect calorimetry
Measured: 24 hours
Postprandial substrate oxidation
Postprandial substrate oxidation determined by indirect calorimetry
Measured: 24 hours
Palatability
Measured by 0-100 mm visual analogue scale
Measured: 24 hours
Fasting cholesterol, HDL, and LDL concentrations
Fasting cholesterol, HDL, and LDL concentrations in serum samples
Measured: 24 hours
Postprandial cholesterol, HDL, and LDL concentrations
Postprandial cholesterol, HDL, and LDL concentrations in serum samples
Measured: 24 hours
Fasting leptin concentrations
Fasting leptin concentrations in serum samples
Measured: 24 hours
Postprandial leptin concentrations
Postprandial leptin concentrations in serum samples
Measured: 24 hours
Macronutrient intake
Macronutrient intake across 24-h
Measured: 24 hours
Fasting FGF21 concentrations
Fasting FGF21 concentrations in serum samples
Measured: 24 hours
Postprandial FGF21 concentrations
Postprandial FGF21 concentrations in serum samples
Measured: 24 hours
Eating rate
Time taken to eat test meals
Measured: 24 hours
Body mass
Body mass
Measured: 24 hours
Waist and hip circumference
Waist and hip circumference, waist:hip ratio
Measured: 24 hours
Fasting haematology profile
Fasting haematology profile including WBC, RBC, HGB, haematocrit, platelet count
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start4 Dec 2017
- Primary completion21 May 2021
- Study completion21 May 2021
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 Nutrition and Energy BalanceStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509610
- Sponsor's protocol ID
- EP 17/18 87
- Status last verified
- Jun 2021
- First submitted
- 9 Apr 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
PubMed 29028272Betts 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 24898233Erickson J, Sadeghirad B, Lytvyn L, Slavin J, Johnston BC. The Scientific Basis of Guideline Recommendations on Sugar Intake: A Systematic Review. Ann Intern Med. 2017 Feb 21;166(4):257-267. doi: 10.7326/M16-2020. Epub 2016 Dec 20.
PubMed 27992898Hengist A, Davies RG, Rogers PJ, Brunstrom JM, van Loon LJC, Walhin JP, Thompson D, Koumanov F, Betts JA, Gonzalez JT. Restricting sugar or carbohydrate intake does not impact physical activity level or energy intake over 24 h despite changes in substrate use: a randomised crossover study in healthy men and women. Eur J Nutr. 2023 Mar;62(2):921-940. doi: 10.1007/s00394-022-03048-x. Epub 2022 Nov 3.
PubMed 36326863
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Responses to Manipulating Dietary Carbohydrate Content and Type on All Major Aspects of Energy Balance
- ClinicalTrials.gov ID
- NCT03509610
- Acronym / sponsor ID
- EP 17/18 87
- Conditions
- Nutrition and Energy Balance
- Keywords
- Nutrition, Carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 26 Apr 2018 (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.
Sugar is perceived negatively, leading to government taxation and targets to reduce consumption. These actions have been taken based on the limited evidence that high-sugar diets are associated with greater total energy intake. However, energy intake comprises just one half of the energy balance equation (e.g. balance = intake - expenditure). Without considering energy expenditure, it is impossible to understand the effects of sugar on health. Sugar, and perhaps total carbohydrate intake, may be important for energy balance - perhaps by stimulating increased energy expenditure.
Understanding dietary regulators of energy balance is more important than ever before, because diseases like obesity are a consequence of energy surplus (i.e. energy intake > energy expenditure). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the acute (e.g. 24-hour) responses to manipulating dietary carbohydrate and sugar content on energy balance and health.
This research will contribute to enabling individuals to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults will be recruited to a randomised crossover study. Measures of energy intake, energy expenditure, metabolic health, appetite, food preference, and gut microbiota will be taken. All laboratory trials will take place at the University of Bath.
Three diets will be investigated:
- Control - reflecting the composition of a typical European diet
- Low sugar - the same composition of a typical European diet but with <5% energy intake from sugar
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
The study will consist of a 3-day lead-in period with the control diet followed by one trial day with each diet.
Detailed description
Dietary sugar is increasingly perceived in a negative way. This has led to taxation by government and guidelines by global public health bodies to reduce sugar intake to <5% of energy intake. All available public health guidelines regarding sugar advocate a reduction in sugar intake, despite a lack of evidence to support these recommendations. These guidelines focus on the association between sugar intake and energy intake, without regard for energy expenditure. This oversimplifies situations in which energy surplus is pathological, for example in diseases like obesity. This complexity is demonstrated by evidence that dietary sugar intake is decreasing in the United Kingdom, whilst rates of obesity have increased in the same timeframe.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Carbohydrate availability dictates the capacity to perform physical work. However, the role of carbohydrate in regulating physical activity behaviours has only recently been considered. Ingestion of a carbohydrate-rich breakfast causes a significant increase in 24-hour PAEE compared with no breakfast consumption before midday. The magnitude of this difference is greatest prior to midday, near to when carbohydrate had been ingested and when glucose uptake to peripheral tissue is increased. This points towards a stimulatory role of carbohydrate or sugar on PAEE when carbohydrate is readily available to peripheral tissue. The amount of carbohydrate present in skeletal muscle is dictated by the amount of carbohydrate in the diet. As physical activity is performed by skeletal muscle, dietary carbohydrate intake may regulate physical activity behaviour. Consequently, reducing total carbohydrate intake may result in reduced PAEE.
Studies in which carbohydrate has been manipulated and physical activity has been measured have not been sufficient in answering this research question. Often self-report measures of physical activity are used, which are not sensitive enough to discern meaningful differences. Studies which have measured physical activity objectively, i.e. using pedometers or accelerometers, are confounded by a lack of information about actual carbohydrate intake or concurrent prescription of exercise interventions. Furthermore, government targets of reduced sugar intake to <5% of total energy intake are not aimed at overall carbohydrate intake per se. In the breakfast study mentioned, sugar intake was significantly greater amongst individuals who ate breakfast compared with individuals who fasted until midday. Therefore, it is also plausible that a regulatory role of carbohydrate on PAEE may be due to the type of carbohydrate rather than the absolute amount.
If the availability of carbohydrate to peripheral tissue plays a regulatory role on PAEE, then theoretically the effects of manipulating the amount or type of carbohydrate will be detectable acutely, within 24 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Other: DietDiet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat |
| LOW SUG | Experimental | Other: DietDiet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat |
| LOW CHO | Experimental | Other: DietDiet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
Key exclusion criteria (5 listed)
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
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 |
|---|---|---|
| DietMacronutrient composition (specifically type and/or amount of carbohydrate) is manipulated | Other | CONTROL, LOW CHO, LOW SUG |
Primary outcome
24-hour physical activity energy expenditure (kcal/day)
Time frame: 24 hours
24-hour physical activity energy expenditure (kcal/day)
27 secondary outcomes
24-hour energy intake (kcal/day)
Time frame: 24 hours
Fasting glucose concentrations
Time frame: 24 hours
Postprandial glucose concentrations
Time frame: 24 hours
Fasting insulin concentrations
Time frame: 24 hours
Postprandial insulin concentrations
Time frame: 24 hours
Fasting triglyceride concentrations
Time frame: 24 hours
Postprandial triglyceride concentrations
Time frame: 24 hours
Fasting non-esterified fatty acid concentrations
Time frame: 24 hours
Postprandial non-esterified fatty acid concentrations
Time frame: 24 hours
Fasting beta-hydroxybutyrate concentrations
Time frame: 24 hours
Postprandial beta-hydroxybutyrate concentrations
Time frame: 24 hours
Subjective appetite
Time frame: 24 hours
Food preference ratings
Time frame: 24 hours
Resting substrate oxidation
Time frame: 24 hours
Postprandial substrate oxidation
Time frame: 24 hours
Palatability
Time frame: 24 hours
Fasting cholesterol, HDL, and LDL concentrations
Time frame: 24 hours
Postprandial cholesterol, HDL, and LDL concentrations
Time frame: 24 hours
Fasting leptin concentrations
Time frame: 24 hours
Postprandial leptin concentrations
Time frame: 24 hours
Macronutrient intake
Time frame: 24 hours
Fasting FGF21 concentrations
Time frame: 24 hours
Postprandial FGF21 concentrations
Time frame: 24 hours
Eating rate
Time frame: 24 hours
Body mass
Time frame: 24 hours
Waist and hip circumference
Time frame: 24 hours
Fasting haematology profile
Time frame: 24 hours
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 18 Jun 2021.
- Background: PubMed 29028272Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
- 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.
- Background: PubMed 27992898Erickson J, Sadeghirad B, Lytvyn L, Slavin J, Johnston BC. The Scientific Basis of Guideline Recommendations on Sugar Intake: A Systematic Review. Ann Intern Med. 2017 Feb 21;166(4):257-267. doi: 10.7326/M16-2020. Epub 2016 Dec 20.
- Derived from this study: PubMed 36326863Hengist A, Davies RG, Rogers PJ, Brunstrom JM, van Loon LJC, Walhin JP, Thompson D, Koumanov F, Betts JA, Gonzalez JT. Restricting sugar or carbohydrate intake does not impact physical activity level or energy intake over 24 h despite changes in substrate use: a randomised crossover study in healthy men and women. Eur J Nutr. 2023 Mar;62(2):921-940. doi: 10.1007/s00394-022-03048-x. Epub 2022 Nov 3.
- SACN 2015 Report on Carbohydrates and HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Nutrition and Energy Balance
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Active, not recruiting
Food Genetics Behavior Study
Obesity, Childhood
Recruiting
Effects of Ultra Processed Food on Intestinal Energy Harvest
Obesity and Overweight
Active, not recruiting
Circadian Misalignment and Energy Balance
Obesity
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Nutrition and Energy Balance, run by University of Bath 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 5 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 18 Jun 2021. 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?
24-hour physical activity energy expenditure (kcal/day) (time frame: 24 hours). 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 NCT03509610, 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 18 Jun 2021.