Physical ActivityNCT03574987
Dietary Carbohydrate Manipulation and Energy Balance: RCT
A study testing Diet in people with Physical Activity and Diet Modification, run by University of Bath at 1 site in United Kingdom.
Trial summary
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Diet Modification
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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/contraceptive use
- No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)
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%)
- Use of antibiotic medication in the last 3 months
- Use of prebiotic or probiotic products in the last month
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 Effect of Dietary Carbohydrate Manipulation on All Major Aspects of Energy Balance: A 12-week Randomised Controlled Trial
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted, and the final third of participants will eat a diet where both sugar and total carbohydrates are restricted and replaced with fat.
Read the detailed description
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 is only one half of the energy balance equation (energy in vs energy out). Without considering energy expenditure, it is impossible to fully understand the effects of sugar on health. Removing dietary sugar or carbohydrates from the diet may influence energy balance through mechanisms other than energy intake - for example by reducing levels of physical activity.
Understanding dietary regulators of energy balance is more important than ever because diseases like obesity are a consequence of energy surplus (i.e. energy in > energy out). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the responses to manipulating dietary carbohydrate and sugar content on energy balance and health. This research will enable the public to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults, aged 18-65 years will be recruited to take part in an intervention study with measures of energy intake, energy expenditure, metabolic health, gut microbiota, and appetite. All laboratory trials will take place at the University of Bath. Participants will be randomised to consume one of three diets for a period of 12 weeks, with laboratory visits at baseline, at week 4, and at week 12:
- CONTROL (moderate sugar) - 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, replacing carbohydrate energy with fat
- Conditions
- Physical Activity, Diet Modification
- Being tested
- Diet
- Keywords
- Physical Activity, Nutrition, Carbohydrates, Sugar, Energy Balance
- Medical subject headings
- Motor Activity
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.
Physical Activity Energy Expenditure (kJ/Day or kcal/Day)
24-hour physical activity energy expenditure (kJ/day or kcal/day)
Measured: 7 days (across 12 weeks) - Primary outcome at week 4
Secondary outcomes (28)
Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes)
Time spent in different physical activity intensities (MET categories) (minutes)
Measured: 7 days (across 12 weeks)
Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal)
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Measured: 7 days (across 12 weeks)
Energy Intake and Dietary Macronutrient Composition
Estimated using food diaries, 7 days each time concurrently measured with PAEE and 3 days per week for the rest of the intervention
Measured: 12 weeks
Body Mass
Measured weekly using electric scales
Measured: 12 weeks
Bone Mineral Density
Bone mineral density measured using dual x-ray absorptiometry
Measured: 12 weeks
Bone Mineral Content
Bone mineral content measured using dual x-ray absorptiometry
Measured: 12 weeks
Fat Mass
Fat mass measured using dual x-ray absorptiometry
Measured: 12 weeks
Fat-free Mass
Fat-free mass measured using dual x-ray absorptiometry
Measured: 12 weeks
Android Fat Mass
Android fat mass measured using dual x-ray absorptiometry
Measured: 12 weeks
Gynoid Fat Mass
Gynoid fat mass measured using dual x-ray absorptiometry
Measured: 12 weeks
Resting Metabolic Rate
Resting metabolic rate will be measured using indirect calorimetry
Measured: 12 weeks
Substrate Oxidation
Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise
Measured: 12 weeks
Waist and Hip Circumference
Waist and hip circumference will be measured using a tape measure
Measured: 12 weeks
Step Count
Measured daily using pedometers
Measured: 12 weeks
Fasting Metabolite/Hormone Profile
Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)
Measured: 12 weeks
Postprandial Metabolite/Hormone Profile
Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)
Measured: 4 hours (across 12 weeks)
Blood Pressure
Measured using an automated sphygmomanometer
Measured: 12 weeks
Food Preference Ratings
Food preference ratings determined by bespoke computer software
Measured: 12 weeks
Subjective Appetite and Mood Ratings
Measured by 0-100 mm visual analogue scale
Measured: 12 weeks
Interstitial Glucose Concentrations
Measured using research-grade freestyle libre glucose monitors. Measured pre-, during- and at the end of the intervention
Measured: 14 days (across 12 weeks)
Adipose Tissue Gene Expression
Expression of a panel of genes related to glucose metabolism in adipose biopsies using real-time polymerase chain reaction
Measured: 12 weeks
Adipose Tissue Protein Expression
Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot
Measured: 12 weeks
Muscle Tissue Gene Expression
Expression of a panel of genes related to glucose metabolism in muscle biopsies using real-time polymerase chain reaction
Measured: 12 weeks
Muscle Tissue Protein Expression
Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot
Measured: 12 weeks
Muscle Glycogen Concentrations
Glycogen concentrations measured from vastus lateralis muscle samples
Measured: 12 weeks
Gut Microbiome Characterisation
Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques
Measured: 12 weeks
Urinary Acetoacetate Concentrations
Will be measured using handheld sticks
Measured: 12 weeks
Urine Urea Nitrogen Excretion
Will be measured across trial days
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Oct 2018
- Primary completion11 Feb 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Parallel groups
- Model description
- Randomised controlled trial with 3 arms. One arm is a typical diet (50% CHO, 20% SUG), one arm is low sugar (50% CHO, \<5% SUG), one arm is low carbohydrate (\<8% CHO, \<5% SUG). Stratified by sex and physical activity level (PAL).
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT03574987
- Sponsor's protocol ID
- CHEB-Intervention
- Status last verified
- Jan 2024
- First submitted
- 20 Jun 2018
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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, Walhin JP, Buniam J, Merrell LH, Rogers L, Bradshaw L, Moreno-Cabanas A, Rogers PJ, Brunstrom JM, Hodson L, van Loon LJC, Barton W, O'Donovan C, Crispie F, O'Sullivan O, Cotter PD, Proctor K, Betts JA, Koumanov F, Thompson D, Gonzalez JT. Ketogenic diet but not free-sugar restriction alters glucose tolerance, lipid metabolism, peripheral tissue phenotype, and gut microbiome: RCT. Cell Rep Med. 2024 Aug 20;5(8):101667. doi: 10.1016/j.xcrm.2024.101667. Epub 2024 Aug 5.
PubMed 39106867Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.
PubMed 34986271
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Carbohydrate Manipulation on All Major Aspects of Energy Balance: A 12-week Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03574987
- Acronym / sponsor ID
- CHEB-Intervention
- Conditions
- Physical Activity, Diet Modification
- Keywords
- Physical Activity, Nutrition, Carbohydrates, Sugar, Energy Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 17 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted, and the final third of participants will eat a diet where both sugar and total carbohydrates are restricted and replaced with fat.
Detailed description
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 is only one half of the energy balance equation (energy in vs energy out). Without considering energy expenditure, it is impossible to fully understand the effects of sugar on health. Removing dietary sugar or carbohydrates from the diet may influence energy balance through mechanisms other than energy intake - for example by reducing levels of physical activity.
Understanding dietary regulators of energy balance is more important than ever because diseases like obesity are a consequence of energy surplus (i.e. energy in > energy out). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the responses to manipulating dietary carbohydrate and sugar content on energy balance and health. This research will enable the public to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults, aged 18-65 years will be recruited to take part in an intervention study with measures of energy intake, energy expenditure, metabolic health, gut microbiota, and appetite. All laboratory trials will take place at the University of Bath. Participants will be randomised to consume one of three diets for a period of 12 weeks, with laboratory visits at baseline, at week 4, and at week 12:
- CONTROL (moderate sugar) - 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, replacing carbohydrate energy with fat
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial with 3 arms. One arm is a typical diet (50% CHO, 20% SUG), one arm is low sugar (50% CHO, <5% SUG), one arm is low carbohydrate (<8% CHO, <5% SUG). Stratified by sex and physical activity level (PAL).
| 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/contraceptive use
- No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)
Key exclusion criteria (7 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
Physical Activity Energy Expenditure (kJ/Day or kcal/Day)
Time frame: 7 days (across 12 weeks) - Primary outcome at week 4
24-hour physical activity energy expenditure (kJ/day or kcal/day)
28 secondary outcomes
Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes)
Time frame: 7 days (across 12 weeks)
Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal)
Time frame: 7 days (across 12 weeks)
Energy Intake and Dietary Macronutrient Composition
Time frame: 12 weeks
Body Mass
Time frame: 12 weeks
Bone Mineral Density
Time frame: 12 weeks
Bone Mineral Content
Time frame: 12 weeks
Fat Mass
Time frame: 12 weeks
Fat-free Mass
Time frame: 12 weeks
Android Fat Mass
Time frame: 12 weeks
Gynoid Fat Mass
Time frame: 12 weeks
Resting Metabolic Rate
Time frame: 12 weeks
Substrate Oxidation
Time frame: 12 weeks
Waist and Hip Circumference
Time frame: 12 weeks
Step Count
Time frame: 12 weeks
Fasting Metabolite/Hormone Profile
Time frame: 12 weeks
Postprandial Metabolite/Hormone Profile
Time frame: 4 hours (across 12 weeks)
Blood Pressure
Time frame: 12 weeks
Food Preference Ratings
Time frame: 12 weeks
Subjective Appetite and Mood Ratings
Time frame: 12 weeks
Interstitial Glucose Concentrations
Time frame: 14 days (across 12 weeks)
Adipose Tissue Gene Expression
Time frame: 12 weeks
Adipose Tissue Protein Expression
Time frame: 12 weeks
Muscle Tissue Gene Expression
Time frame: 12 weeks
Muscle Tissue Protein Expression
Time frame: 12 weeks
Muscle Glycogen Concentrations
Time frame: 12 weeks
Gut Microbiome Characterisation
Time frame: 12 weeks
Urinary Acetoacetate Concentrations
Time frame: 12 weeks
Urine Urea Nitrogen Excretion
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 39106867Hengist A, Davies RG, Walhin JP, Buniam J, Merrell LH, Rogers L, Bradshaw L, Moreno-Cabanas A, Rogers PJ, Brunstrom JM, Hodson L, van Loon LJC, Barton W, O'Donovan C, Crispie F, O'Sullivan O, Cotter PD, Proctor K, Betts JA, Koumanov F, Thompson D, Gonzalez JT. Ketogenic diet but not free-sugar restriction alters glucose tolerance, lipid metabolism, peripheral tissue phenotype, and gut microbiome: RCT. Cell Rep Med. 2024 Aug 20;5(8):101667. doi: 10.1016/j.xcrm.2024.101667. Epub 2024 Aug 5.
- Derived from this study: PubMed 34986271Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.
- 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.
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 Physical Activity and Diet Modification, 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 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 17 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (time frame: 7 days (across 12 weeks) - Primary outcome at week 4). 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 NCT03574987, which also lists 5 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 17 Jun 2024.