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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Active Comparator | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat |
|
| LOW SUG | Experimental | Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat |
|
| LOW CHO | Experimental | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Energy Expenditure (kJ/Day or kcal/Day) | 24-hour physical activity energy expenditure (kJ/day or kcal/day) | 7 days (across 12 weeks) - Primary outcome at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes) | Time spent in different physical activity intensities (MET categories) (minutes) | 7 days (across 12 weeks) |
| Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Health, University of Bath | Bath | BA2 7AY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29028272 | Background | 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. | |
| 24898233 | Background | Betts 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CONTROL | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
| FG001 | LOW SUG | Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
| FG002 | LOW CHO | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CONTROL | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
| BG001 | LOW SUG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity Energy Expenditure (kJ/Day or kcal/Day) | 24-hour physical activity energy expenditure (kJ/day or kcal/day) | Dropout and/or missing data (device malfunction) between weeks 4 and 12. | Posted | Mean | 95% Confidence Interval | kcal/d | 7 days (across 12 weeks) - Primary outcome at week 4 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CONTROL | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sports injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Javier Gonzalez | University of Bath | 0122538 | 5518 | j.t.gonzalez@bath.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2023 | Jan 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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).
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Energy expended in different physical activity intensities (MET categories) (kJ or kcal) |
| 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 | 12 weeks |
| Body Mass | Measured weekly using electric scales | 12 weeks |
| Bone Mineral Density | Bone mineral density measured using dual x-ray absorptiometry | 12 weeks |
| Bone Mineral Content | Bone mineral content measured using dual x-ray absorptiometry | 12 weeks |
| Fat Mass | Fat mass measured using dual x-ray absorptiometry | 12 weeks |
| Fat-free Mass | Fat-free mass measured using dual x-ray absorptiometry | 12 weeks |
| Android Fat Mass | Android fat mass measured using dual x-ray absorptiometry | 12 weeks |
| Gynoid Fat Mass | Gynoid fat mass measured using dual x-ray absorptiometry | 12 weeks |
| Resting Metabolic Rate | Resting metabolic rate will be measured using indirect calorimetry | 12 weeks |
| Substrate Oxidation | Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise | 12 weeks |
| Waist and Hip Circumference | Waist and hip circumference will be measured using a tape measure | 12 weeks |
| Step Count | Measured daily using pedometers | 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) | 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) | 4 hours (across 12 weeks) |
| Blood Pressure | Measured using an automated sphygmomanometer | 12 weeks |
| Food Preference Ratings | Food preference ratings determined by bespoke computer software | 12 weeks |
| Subjective Appetite and Mood Ratings | Measured by 0-100 mm visual analogue scale | 12 weeks |
| Interstitial Glucose Concentrations | Measured using research-grade freestyle libre glucose monitors. Measured pre-, during- and at the end of the intervention | 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 | 12 weeks |
| Adipose Tissue Protein Expression | Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot | 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 | 12 weeks |
| Muscle Tissue Protein Expression | Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot | 12 weeks |
| Muscle Glycogen Concentrations | Glycogen concentrations measured from vastus lateralis muscle samples | 12 weeks |
| Gut Microbiome Characterisation | Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques | 12 weeks |
| Urinary Acetoacetate Concentrations | Will be measured using handheld sticks | 12 weeks |
| Urine Urea Nitrogen Excretion | Will be measured across trial days | 12 weeks |
| 27992898 | Background | Erickson 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. |
| 34986271 | Derived | Bergwall 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. |
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
| BG002 | LOW CHO | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | LOW CHO | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated |
|
|
| Secondary | Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes) | Time spent in different physical activity intensities (MET categories) (minutes) | Not Posted | 7 days (across 12 weeks) | Participants |
| Secondary | Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal) | Energy expended in different physical activity intensities (MET categories) (kJ or kcal) | Not Posted | 7 days (across 12 weeks) | Participants |
| Secondary | 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 | Not Posted | 12 weeks | Participants |
| Secondary | Body Mass | Measured weekly using electric scales | Not Posted | 12 weeks | Participants |
| Secondary | Bone Mineral Density | Bone mineral density measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Bone Mineral Content | Bone mineral content measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Fat Mass | Fat mass measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Fat-free Mass | Fat-free mass measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Android Fat Mass | Android fat mass measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Gynoid Fat Mass | Gynoid fat mass measured using dual x-ray absorptiometry | Not Posted | 12 weeks | Participants |
| Secondary | Resting Metabolic Rate | Resting metabolic rate will be measured using indirect calorimetry | Not Posted | 12 weeks | Participants |
| Secondary | Substrate Oxidation | Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise | Not Posted | 12 weeks | Participants |
| Secondary | Waist and Hip Circumference | Waist and hip circumference will be measured using a tape measure | Not Posted | 12 weeks | Participants |
| Secondary | Step Count | Measured daily using pedometers | Not Posted | 12 weeks | Participants |
| Secondary | 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) | Not Posted | 12 weeks | Participants |
| Secondary | 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) | Not Posted | 4 hours (across 12 weeks) | Participants |
| Secondary | Blood Pressure | Measured using an automated sphygmomanometer | Not Posted | 12 weeks | Participants |
| Secondary | Food Preference Ratings | Food preference ratings determined by bespoke computer software | Not Posted | 12 weeks | Participants |
| Secondary | Subjective Appetite and Mood Ratings | Measured by 0-100 mm visual analogue scale | Not Posted | 12 weeks | Participants |
| Secondary | Interstitial Glucose Concentrations | Measured using research-grade freestyle libre glucose monitors. Measured pre-, during- and at the end of the intervention | Not Posted | 14 days (across 12 weeks) | Participants |
| Secondary | Adipose Tissue Gene Expression | Expression of a panel of genes related to glucose metabolism in adipose biopsies using real-time polymerase chain reaction | Not Posted | 12 weeks | Participants |
| Secondary | Adipose Tissue Protein Expression | Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot | Not Posted | 12 weeks | Participants |
| Secondary | Muscle Tissue Gene Expression | Expression of a panel of genes related to glucose metabolism in muscle biopsies using real-time polymerase chain reaction | Not Posted | 12 weeks | Participants |
| Secondary | Muscle Tissue Protein Expression | Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot | Not Posted | 12 weeks | Participants |
| Secondary | Muscle Glycogen Concentrations | Glycogen concentrations measured from vastus lateralis muscle samples | Not Posted | 12 weeks | Participants |
| Secondary | Gut Microbiome Characterisation | Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques | Not Posted | 12 weeks | Participants |
| Secondary | Urinary Acetoacetate Concentrations | Will be measured using handheld sticks | Not Posted | 12 weeks | Participants |
| Secondary | Urine Urea Nitrogen Excretion | Will be measured across trial days | Not Posted | 12 weeks | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | LOW SUG | Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | LOW CHO | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated | 0 | 18 | 0 | 18 | 1 | 18 |
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| Male |
|