Diet Induced ThermogenesisThermicFoodsNCT02937298
Thermic Effects of Some Scottish Plant Foods
A study testing Berry Treatment, Sea Buckthorn Treatment and Wild Garlic Treatment in people with Diet Induced Thermogenesis and Obesity Control, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst over 50% of a person's energy requirement goes towards the maintenance of physiological functions, around 40% is used for physical activity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Induced Thermogenesis, Obesity Control
- What is being tested?
- Berry Treatment, Sea Buckthorn Treatment and Wild Garlic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 17 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged between 18-50 years
- Body mass index between 18.5 - 25.0 kg/m2
Who cannot join
- Suffering from thyroid disorders, metabolic/genetic diseases
- On prescription medications known to affect metabolism including hormonal contraceptives and thyroid medications
- Post-menopausal
- Allergic/intolerant to any foods
- Eating disorders
- Alcohol and/or other substance misuse issues
- Extreme intake of caffeine (more than 6 cups of tea and/or coffee per day)
- Smoking
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, Human Nutrition Unit
Aberdeen, AB25 2ZD
About this study
Official title: The Thermic Effect of Some Plant Foods Native to Scotland: A Pilot Study.
Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst over 50% of a person's energy requirement goes towards the maintenance of physiological functions, around 40% is used for physical activity. In addition to this, around 10-15% of energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced Thermogenesis is the increase in energy expenditure following a meal, and represents the energy utilised for the digestion and metabolism of food. Some nutrients such as proteins require more energy to digest and therefore produce a greater DIT than others. In addition to this, some food components are able to independently stimulate calorie burning. For example caffeine, chilli, ginger and green tea have been shown to induce calorie burning through DIT. Therefore the inclusion of such foods in the diet could increase energy expenditure and thereby help in weight control.
The objective of this study is to determine the DIT effects of some plant foods that are native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to be effective, these foods could then be used to develop dietary strategies for weight control in Scotland.
Read the detailed description
Obesity prevalence is increasing around the world and the United Kingdom is no exception. Latest statistics show that approximately 25% of the UK population is obese and is predicted to rise to 70% by 2020 if present trends continue. Obesity is particularly widespread in Scotland where approximately 62% of the population are of a BMI over 25kg/m2. Curtailing obesity rates is a public health priority as excess weight is also the greatest predictor of other co-morbidities such as cardiovascular disease, cancer and diabetes, and hence collectively exerts a significant toll on the health and economic burden of the country.
Weight gain occurs primarily due to an imbalance in energy balance status where energy intake outweighs expenditure. Energy expenditure (EE) in adults consists of three components: basal metabolism (50-70% of EE), physical activity (30-40% of EE) and diet induced thermogenesis (DIT). The latter is described as the thermic effect of food and is the increase in EE above Basal Metabolic Rate after a meal, and usually ranges between 3-10% of total EE (depending on the composition of the meal). Whilst cornerstone approaches to weight control have focused on strategies to reduce energy intake and increase physical activity, the still escalating obesity levels show that this approach is ineffective in the long term possibly due to poor long-term compliance to dietary regimes and adequate physical activity. Thus it is being increasingly recognised that the most sustainable long-term strategy for reducing obesity is making small diet and lifestyle changes that would positively influence energy regulatory mechanisms targeted at preventing a positive energy balance. It is also now recognised that genetic predispositions to a slow mechanism characterised by a slow metabolic rate and capacity for fat oxidation also determines an individual's propensity to weight gain. Furthermore, studies have shown that weight loss and reduced food intake result in an attenuation of EE possibly due to the loss of lean mass and improved metabolic efficiency. The regular consumption of high DIT foods which could increase EE and fat oxidation whilst circumventing these energy sparing mechanisms may have significant potential in long-term weight control. Indeed studies demonstrating pronounced obesity in mice whose DIT mechanism were inactivated indicates the important role thermogenesis plays in weight control
Food components such as chilli (capsaicin), ginger, mustard, pepper, caffeine, green tea (flavanols) and medium-chain triglycerides have been demonstrated as increasing DIT. The thermogenic effects of these compounds have been shown to be mainly via the sympathetic nervous system. Pharmacological agents such as ephedrine and salicylate as well as food constituents such as methylxanthines (theophylline and caffeine) and caffeine have been shown to possess sympathomimetic properties and induce fat oxidation and thermogenesis in effector cells by stimulating the release of noradrenalin. Flavanoids such as green tea catechins have also been shown to stimulate this pathway. Sympathetically released noradrenalin has been shown to activate Beta3adrenoceptors and thereby induce thermogenesis and fat oxidation in peripheral tissues as well as activate uncoupling protein (UCP1) that mediates thermogenesis in brown adipose tissue (BAT). Plant phenolics have also been shown to demonstrate thermogenic effects, particularly Oleuropein, green tea catechins, Kaempferol, flavanol glycosides, stilbenes and quercetin.
The objective of the present pilot study is to assess the thermogenic effects of some plant foods native to Scotland that contain the above phytochemicals. Specifically, the study will investigate the thermogenic effects of berries (blackberries [Rubus sp.], blueberries [Vaccinium corymbosum] and red raspberries [Rubus idaeus L]), wild garlic (Allium ursinum) and sea buckthorn (Hippophae rhamnoides). Blackberries, blueberries and raspberries have been shown to be rich in flavonoids and phenolics including catechins and raspberry ketones which have been suggested to be thermogenic. These berries are also rich in anthocyanins such as cyanidin-3-glucoside which has been shown to potentially promote thermogenesis by upregulating UCP1. Furthermore, blueberries have been shown to be a good source of stilbenes such as resveratrol and pterostilbene which have demonstrated thermic effects elsewhere. Similarly, sea buckthorn has been reported to contain catechins, epicatechins and flavonols such as isorhamnetin, quercetin and kaempferol. Sea buckthorn is also rich in carotenoids, especially those with provitamin A activity that have been shown to upregulate the expression of UCP1 and thereby influence thermogenesis. Wild garlic contains Sulphur containing compounds such as alliin and Allicin derivatives (diallyldisulphide) that in studies using garlic have shown thermogenic activity by enhancing noradrenalin secretion and stimulating brown adipose tissue. Indeed the total thiosulfinate content in wild garlic has been shown to be comparable to garlic.
The presence of thermogenic compounds in these plant products logically suggests that they may have a thermic effect in humans and this forms the rationale for the present study. No studies have investigated the thermic effects of these foods in humans and their therapeutic potential in weight control from a thermogenesis perspective. The proposed pilot study will provide preliminary data on the thermic effects of these Scottish foods and provide a basis for future research.
- Conditions
- Diet Induced Thermogenesis, Obesity Control
- Being tested
- Control Meal, Berry Treatment, Sea Buckthorn Treatment, Wild Garlic Treatment
- Keywords
- Diet Induced Thermogenesis, Obesity, Energy balance, Energy expenditure, berries, Sea Buckthorn, Wild garlic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control MealDietary supplement
This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream
Berry TreatmentDietary supplement
This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a berry smoothie. The berry smoothie consists of blueberries, raspberries and blackberries.
Sea Buckthorn TreatmentDietary supplement
This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a sea buckthorn berry smoothie.
Wild Garlic TreatmentDietary supplement
This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream. The wild garlic will be prepared and served as a dip alongside.
| Study group | Role | What they receive |
|---|---|---|
| Control Meal | Experimental | Control meal using standard breakfast foods. Receives: Dietary Supplement: Control Meal |
| Berry Treatment | Experimental | This will consist of standard breakfast foods plus a berry smoothie. Receives: Dietary Supplement: Berry Treatment |
| Sea Buckthorn Treatment | Experimental | This will consist of standard breakfast foods plus a sea buckthorn berry smoothie. Receives: Dietary Supplement: Sea Buckthorn Treatment |
| Wild Garlic Treatment | Experimental | This will consist of standard breakfast foods plus a wild garlic dip. Receives: Dietary Supplement: Wild Garlic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Induced Thermogenesis
Measured as the difference in Resting Metabolic Rate (RMR) during fasting and postprandial states
Measured: Baseline then for 15 minutes hourly for 5 hours post prandial
Secondary outcomes (2)
Substrate utilisation for energy metabolism
Based on the Respiratory Quotient (RQ) from RMR measurement and urinary urea, the proportion of carbohydrate, fat and protein used for energy production will be estimated.
Measured: Baseline and hourly for 5 hours post prandial
Satiety and palatability of the test meals.
Measured using 100mm continuous-line scales anchored at each end with opposing answers to satiety and palatability related questions
Measured: Immediately before and after consumption of the test meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet Induced ThermogenesisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viren Ranawana, MSc, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937298
- Sponsor's protocol ID
- 2016/RINH/2
- Acronym
- ThermicFoods
- Status last verified
- May 2018
- First submitted
- 14 Oct 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thermic Effect of Some Plant Foods Native to Scotland: A Pilot Study.
- ClinicalTrials.gov ID
- NCT02937298
- Acronym / sponsor ID
- ThermicFoods / 2016/RINH/2
- Conditions
- Diet Induced Thermogenesis, Obesity Control
- Keywords
- Diet Induced Thermogenesis, Obesity, Energy balance, Energy expenditure, berries, Sea Buckthorn, Wild garlic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst over 50% of a person's energy requirement goes towards the maintenance of physiological functions, around 40% is used for physical activity. In addition to this, around 10-15% of energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced Thermogenesis is the increase in energy expenditure following a meal, and represents the energy utilised for the digestion and metabolism of food. Some nutrients such as proteins require more energy to digest and therefore produce a greater DIT than others. In addition to this, some food components are able to independently stimulate calorie burning. For example caffeine, chilli, ginger and green tea have been shown to induce calorie burning through DIT. Therefore the inclusion of such foods in the diet could increase energy expenditure and thereby help in weight control.
The objective of this study is to determine the DIT effects of some plant foods that are native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to be effective, these foods could then be used to develop dietary strategies for weight control in Scotland.
Detailed description
Obesity prevalence is increasing around the world and the United Kingdom is no exception. Latest statistics show that approximately 25% of the UK population is obese and is predicted to rise to 70% by 2020 if present trends continue. Obesity is particularly widespread in Scotland where approximately 62% of the population are of a BMI over 25kg/m2. Curtailing obesity rates is a public health priority as excess weight is also the greatest predictor of other co-morbidities such as cardiovascular disease, cancer and diabetes, and hence collectively exerts a significant toll on the health and economic burden of the country.
Weight gain occurs primarily due to an imbalance in energy balance status where energy intake outweighs expenditure. Energy expenditure (EE) in adults consists of three components: basal metabolism (50-70% of EE), physical activity (30-40% of EE) and diet induced thermogenesis (DIT). The latter is described as the thermic effect of food and is the increase in EE above Basal Metabolic Rate after a meal, and usually ranges between 3-10% of total EE (depending on the composition of the meal). Whilst cornerstone approaches to weight control have focused on strategies to reduce energy intake and increase physical activity, the still escalating obesity levels show that this approach is ineffective in the long term possibly due to poor long-term compliance to dietary regimes and adequate physical activity. Thus it is being increasingly recognised that the most sustainable long-term strategy for reducing obesity is making small diet and lifestyle changes that would positively influence energy regulatory mechanisms targeted at preventing a positive energy balance. It is also now recognised that genetic predispositions to a slow mechanism characterised by a slow metabolic rate and capacity for fat oxidation also determines an individual's propensity to weight gain. Furthermore, studies have shown that weight loss and reduced food intake result in an attenuation of EE possibly due to the loss of lean mass and improved metabolic efficiency. The regular consumption of high DIT foods which could increase EE and fat oxidation whilst circumventing these energy sparing mechanisms may have significant potential in long-term weight control. Indeed studies demonstrating pronounced obesity in mice whose DIT mechanism were inactivated indicates the important role thermogenesis plays in weight control
Food components such as chilli (capsaicin), ginger, mustard, pepper, caffeine, green tea (flavanols) and medium-chain triglycerides have been demonstrated as increasing DIT. The thermogenic effects of these compounds have been shown to be mainly via the sympathetic nervous system. Pharmacological agents such as ephedrine and salicylate as well as food constituents such as methylxanthines (theophylline and caffeine) and caffeine have been shown to possess sympathomimetic properties and induce fat oxidation and thermogenesis in effector cells by stimulating the release of noradrenalin. Flavanoids such as green tea catechins have also been shown to stimulate this pathway. Sympathetically released noradrenalin has been shown to activate Beta3adrenoceptors and thereby induce thermogenesis and fat oxidation in peripheral tissues as well as activate uncoupling protein (UCP1) that mediates thermogenesis in brown adipose tissue (BAT). Plant phenolics have also been shown to demonstrate thermogenic effects, particularly Oleuropein, green tea catechins, Kaempferol, flavanol glycosides, stilbenes and quercetin.
The objective of the present pilot study is to assess the thermogenic effects of some plant foods native to Scotland that contain the above phytochemicals. Specifically, the study will investigate the thermogenic effects of berries (blackberries [Rubus sp.], blueberries [Vaccinium corymbosum] and red raspberries [Rubus idaeus L]), wild garlic (Allium ursinum) and sea buckthorn (Hippophae rhamnoides). Blackberries, blueberries and raspberries have been shown to be rich in flavonoids and phenolics including catechins and raspberry ketones which have been suggested to be thermogenic. These berries are also rich in anthocyanins such as cyanidin-3-glucoside which has been shown to potentially promote thermogenesis by upregulating UCP1. Furthermore, blueberries have been shown to be a good source of stilbenes such as resveratrol and pterostilbene which have demonstrated thermic effects elsewhere. Similarly, sea buckthorn has been reported to contain catechins, epicatechins and flavonols such as isorhamnetin, quercetin and kaempferol. Sea buckthorn is also rich in carotenoids, especially those with provitamin A activity that have been shown to upregulate the expression of UCP1 and thereby influence thermogenesis. Wild garlic contains Sulphur containing compounds such as alliin and Allicin derivatives (diallyldisulphide) that in studies using garlic have shown thermogenic activity by enhancing noradrenalin secretion and stimulating brown adipose tissue. Indeed the total thiosulfinate content in wild garlic has been shown to be comparable to garlic.
The presence of thermogenic compounds in these plant products logically suggests that they may have a thermic effect in humans and this forms the rationale for the present study. No studies have investigated the thermic effects of these foods in humans and their therapeutic potential in weight control from a thermogenesis perspective. The proposed pilot study will provide preliminary data on the thermic effects of these Scottish foods and provide a basis for future research.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Meal | Experimental | Dietary Supplement: Control MealControl meal using standard breakfast foods. |
| Berry Treatment | Experimental | Dietary Supplement: Berry TreatmentThis will consist of standard breakfast foods plus a berry smoothie. |
| Sea Buckthorn Treatment | Experimental | Dietary Supplement: Sea Buckthorn TreatmentThis will consist of standard breakfast foods plus a sea buckthorn berry smoothie. |
| Wild Garlic Treatment | Experimental | Dietary Supplement: Wild Garlic TreatmentThis will consist of standard breakfast foods plus a wild garlic dip. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females aged between 18-50 years
- Body mass index between 18.5 - 25.0 kg/m2
Key exclusion criteria (8 listed)
- Suffering from thyroid disorders, metabolic/genetic diseases
- On prescription medications known to affect metabolism including hormonal contraceptives and thyroid medications
- Post-menopausal
- Allergic/intolerant to any foods
- Eating disorders
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 |
|---|---|---|
| Control MealThis will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream | Dietary supplement | Control Meal |
| Berry TreatmentThis will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a berry smoothie. The berry smoothie consists of blueberries, raspberries and blackberries. | Dietary supplement | Berry Treatment |
| Sea Buckthorn TreatmentThis will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a sea buckthorn berry smoothie. | Dietary supplement | Sea Buckthorn Treatment |
| Wild Garlic TreatmentThis will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream. The wild garlic will be prepared and served as a dip alongside. | Dietary supplement | Wild Garlic Treatment |
Primary outcome
Diet Induced Thermogenesis
Time frame: Baseline then for 15 minutes hourly for 5 hours post prandial
Measured as the difference in Resting Metabolic Rate (RMR) during fasting and postprandial states
2 secondary outcomes
Substrate utilisation for energy metabolism
Time frame: Baseline and hourly for 5 hours post prandial
Satiety and palatability of the test meals.
Time frame: Immediately before and after consumption of the test meal.
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 May 2018.
- Individual participant dataSharing planned: No
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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.
Viren Ranawana, MSc, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry Treatment, Sea Buckthorn Treatment and Wild Garlic Treatment in people with Diet Induced Thermogenesis and Obesity Control, run by University of Aberdeen 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 2 inclusion and 8 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 May 2018. 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?
Diet Induced Thermogenesis (time frame: Baseline then for 15 minutes hourly for 5 hours post prandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2018.