HealthyNCT06387940
Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels
A study testing nEB Diet, followed for 36 hours, LC25 Diet, followed for 36 hours and LCEB Diet, followed for 36 hours in people with Healthy, run by University of Surrey at 1 site in United Kingdom.
Trial summary
This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- nEB Diet, followed for 36 hours, LC25 Diet, followed for 36 hours and LCEB Diet, followed for 36 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2019to 20 Nov 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stable weight within ±3 kg over the past three months
- no significant medical history.
Who cannot join
- pregnancy
- breastfeeding,
- using medications that could affect the study's outcomes
- high intake of caffeine and alcohol
- existing eating or psychiatric disorders
- adherence to strict dietary regimens like veganism
- high BMI resulting from significant muscle mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation Into the Postprandial Effects of Varying Calorie Content of Low-Carbohydrate Diets on Human Metabolic Health
This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites.
Read the detailed description
Participants will engage in three distinct eating plans: a standard diet with usual carbohydrate and calorie levels, a low-carb diet with typical calories, and a low-carb diet with reduced calories. Each diet is followed for a single day, with subsequent monitoring to assess how the body processes food and manages hunger after a meal. The goal is to understand the potential metabolic benefits of reducing carbohydrate intake, either alone or in combination with calorie reduction. This research aims to identify simpler dietary strategies that could improve heart health and assist in weight management without the need for severe calorie restriction or fasting, offering valuable insights for enhancing health outcomes in overweight individuals.
- Conditions
- Healthy
- Being tested
- nEB Diet, followed for 36 hours, LC25 Diet, followed for 36 hours, LCEB Diet, followed for 36 hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nEB Diet, followed for 36 hoursOther
nEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet
LC25 Diet, followed for 36 hoursOther
LC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet
LCEB Diet, followed for 36 hoursOther
LCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet
| Study group | Role | What they receive |
|---|---|---|
| normal carbohydrate, energy-balanced diet, (nEB) | Active comparator | provided participants' 100% daily energy needs, following the balanced Eatwell Guide recommendations. Receives: Other: nEB Diet, followed for 36 hours |
| low-carbohydrate, energy-balanced diet, (LCEB) | Active comparator | diet contained just 50g of carbohydrates but still met 100% of the participants' estimated daily energy needs. Receives: Other: LCEB Diet, followed for 36 hours |
| low-carbohydrate, energy-restricted diet, (LC25) | Active comparator | The diet consisted of only 50g of carbohydrates and provided 25% of the estimated daily energy needs. Receives: Other: LC25 Diet, followed for 36 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in blood Measured
Measured with ELISA assay and clinical analyser (INDIKO)
Measured: 8 hours (fasting and post-meal)
Resting metabolic rate
Measured with indirect calorimetry (GEM)
Measured: 8 hours (fasting and post-meal)
Secondary outcomes (2)
Perceived Appetite Scores
Measured with a Visual Analog Scale
Measured: 8 hours (fasting and post-meal)
Food intake
Measured using food diaries
Measured: baseline and after each diet arm for 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start5 Nov 2019
- Primary completion1 Apr 2020
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hayriye Biyikoglu, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387940
- Sponsor's protocol ID
- UEC 2019 008 FHMS
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Postprandial Effects of Varying Calorie Content of Low-Carbohydrate Diets on Human Metabolic Health
- ClinicalTrials.gov ID
- NCT06387940
- Acronym / sponsor ID
- UEC 2019 008 FHMS
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 29 Apr 2024 (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.
This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites.
Detailed description
Participants will engage in three distinct eating plans: a standard diet with usual carbohydrate and calorie levels, a low-carb diet with typical calories, and a low-carb diet with reduced calories. Each diet is followed for a single day, with subsequent monitoring to assess how the body processes food and manages hunger after a meal. The goal is to understand the potential metabolic benefits of reducing carbohydrate intake, either alone or in combination with calorie reduction. This research aims to identify simpler dietary strategies that could improve heart health and assist in weight management without the need for severe calorie restriction or fasting, offering valuable insights for enhancing health outcomes in overweight individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal carbohydrate, energy-balanced diet, (nEB) | Active comparator | Other: nEB Diet, followed for 36 hoursprovided participants' 100% daily energy needs, following the balanced Eatwell Guide recommendations. |
| low-carbohydrate, energy-balanced diet, (LCEB) | Active comparator | Other: LCEB Diet, followed for 36 hoursdiet contained just 50g of carbohydrates but still met 100% of the participants' estimated daily energy needs. |
| low-carbohydrate, energy-restricted diet, (LC25) | Active comparator | Other: LC25 Diet, followed for 36 hoursThe diet consisted of only 50g of carbohydrates and provided 25% of the estimated daily energy needs. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable weight within ±3 kg over the past three months
- no significant medical history.
Key exclusion criteria (7 listed)
- pregnancy
- breastfeeding,
- using medications that could affect the study's outcomes
- high intake of caffeine and alcohol
- existing eating or psychiatric 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 |
|---|---|---|
| nEB Diet, followed for 36 hoursnEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet | Other | normal carbohydrate, energy-balanced diet, (nEB) |
| LC25 Diet, followed for 36 hoursLC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet | Other | low-carbohydrate, energy-restricted diet, (LC25) |
| LCEB Diet, followed for 36 hoursLCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet | Other | low-carbohydrate, energy-balanced diet, (LCEB) |
Primary outcome
Biomarkers in blood Measured
Time frame: 8 hours (fasting and post-meal)
Measured with ELISA assay and clinical analyser (INDIKO)
Resting metabolic rate
Time frame: 8 hours (fasting and post-meal)
Measured with indirect calorimetry (GEM)
2 secondary outcomes
Perceived Appetite Scores
Time frame: 8 hours (fasting and post-meal)
Food intake
Time frame: baseline and after each diet arm for 1 day
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 29 Apr 2024.
- 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.
Hayriye Biyikoglu principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nEB Diet, followed for 36 hours, LC25 Diet, followed for 36 hours and LCEB Diet, followed for 36 hours in people with Healthy, run by University of Surrey 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 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 29 Apr 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?
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?
Biomarkers in blood Measured (time frame: 8 hours (fasting and post-meal)). The study lists 2 primary outcomes in all. 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 29 Apr 2024.