Appetitive BehaviorNCT05449665
Focus on Fibre Study
A study testing Phase 2 - High Fibre and Phase 3 - Low Fibre in people with Appetitive Behavior, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Phase 2 - High Fibre and Phase 3 - Low Fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2022to 31 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
- low habitual fibre intake (<10g/day)
Who cannot join
- Medication exclusion criteria:
- antibiotic use (within the past 3 months due to impact on gut microbiota)
- statins (current)
- aspirin or other NSAIDs or anti-coagulants (current)
- anti-depressants (current)
- smoking or vaping
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- Medical exclusion criteria:
- Females who are planning to be pregnant, are pregnant or are breastfeeding
- Anyone with food allergies, self-reported food sensitivity or intolerance
- Anyone with coeliac disease or gluten intolerance
- Anyone taking medication which may affect their appetite
- Anyone with an eating disorder
- Anyone with diabetes
- Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout
- Anyone suffering from a psychiatric disorder or any type of substance abuse
- Anyone suffering from unregulated thyroid disease
- Other exclusion criteria:
- Anyone following a vegetarian or vegan diet
- Anyone following a weight loss programme (that may be affecting lifestyle, physical activity \& diet)
- Anyone with unsuitable veins for blood sampling
- Anyone who is unable to fluently speak, read and understand English
- Anyone who is unable to comply to an alcohol-free diet for 6 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute, University of Aberdeen
Aberdeen, AB25 2ZD
About this study
Official title: Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre
The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.
- Conditions
- Appetitive Behavior
- Being tested
- Phase 1 - Control, Phase 2 - High Fibre, Phase 3 - Low Fibre
- Keywords
- fibre, appetite control, gut microbiome, glycaemic control
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 - ControlOther
Also called Phase 1 - CTRL
Control diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d).
Fed to energy balance (1.5 x Resting Metabolic Rate, RMR).
Phase 2 - High FibreOther
Also called HF
High Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 30g/day Fibre). Fed ad libitum, contains 20g/day pectin (split over breakfast, lunch and dinner) in drinks/yoghurts which will be compulsory to consume and 10g/day fibre coming from the diet provided.
Phase 3 - Low FibreOther
Also called LF
Low Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 10g/day Fibre). Fed ad libitum.
| Study group | Role | What they receive |
|---|---|---|
| Control - High Fibre - Low Fibre (CTRL - HF - LF) | Experimental | * Phase 1 - CTRL: Control diet with moderate fibre consumption for 13days.
* Phase 2 - HF: ad libitum consumption of HF meals for 13days.
* Phase 3 - LF: ad libitum consumption of LF meals for 13days. Receives: Other: Phase 1 - Control; Other: Phase 2 - High Fibre; Other: Phase 3 - Low Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut hormones to assess appetite response to dietary fibre
measured by acute and chronic changes in plasma ghrelin and peptide YY (PYY)
Measured: At baseline and end of each arm (study days 0, 14, 28 and 42)
Change in subjective hunger to assess appetite response to dietary fibre
measured by acute and chronic changes in appetite using visual analogue scale questionnaires
Measured: At baseline and end of each arm (study days 0, 14, 28 and 42)
Secondary outcomes (3)
Change in gut metabolites (from faecal samples) in response to dietary fibre
measured by changes in faecal short chain fatty acids concentrations
Measured: At baseline and end of each arm (study days 0, 14, 28 and 42)
Change in gut microbiome composition (from faecal samples) in response to dietary fibre
measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA
Measured: At baseline and end of each arm (study days 0, 14, 28 and 42)
Change in glycaemic control in response to dietary fibre
measured by acute and chronic changes in plasma glucose and insulin
Measured: At baseline and end of each arm (study days 0, 14, 28 and 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start14 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: There were issues with recruitment so study was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Johnstone, Prof, Principal investigator, Rowett Institute, University of AberdeenAlexander Ross, Dr, Principal investigator, Rowett Institute, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449665
- Sponsor's protocol ID
- 813
- Status last verified
- May 2024
- First submitted
- 17 Jun 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre
- ClinicalTrials.gov ID
- NCT05449665
- Acronym / sponsor ID
- 813
- Conditions
- Appetitive Behavior
- Keywords
- fibre, appetite control, gut microbiome, glycaemic control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were issues with recruitment so study was stopped
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Jul 2022 (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.
The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control - High Fibre - Low Fibre (CTRL - HF - LF) | Experimental | Other: Phase 1 - Control, Other: Phase 2 - High Fibre, Other: Phase 3 - Low Fibre* Phase 1 - CTRL: Control diet with moderate fibre consumption for 13days. * Phase 2 - HF: ad libitum consumption of HF meals for 13days. * Phase 3 - LF: ad libitum consumption of LF meals for 13days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
- low habitual fibre intake (<10g/day)
Key exclusion criteria (22 listed)
- antibiotic use (within the past 3 months due to impact on gut microbiota)
- statins (current)
- aspirin or other NSAIDs or anti-coagulants (current)
- anti-depressants (current)
- smoking or vaping
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 |
|---|---|---|
| Phase 1 - ControlAlso: Phase 1 - CTRLControl diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d). Fed to energy balance (1.5 x Resting Metabolic Rate, RMR). | Other | Control - High Fibre - Low Fibre (CTRL - HF - LF) |
| Phase 2 - High FibreAlso: HFHigh Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 30g/day Fibre). Fed ad libitum, contains 20g/day pectin (split over breakfast, lunch and dinner) in drinks/yoghurts which will be compulsory to consume and 10g/day fibre coming from the diet provided. | Other | Control - High Fibre - Low Fibre (CTRL - HF - LF) |
| Phase 3 - Low FibreAlso: LFLow Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 10g/day Fibre). Fed ad libitum. | Other | Control - High Fibre - Low Fibre (CTRL - HF - LF) |
Primary outcome
Change in gut hormones to assess appetite response to dietary fibre
Time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)
measured by acute and chronic changes in plasma ghrelin and peptide YY (PYY)
Change in subjective hunger to assess appetite response to dietary fibre
Time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)
measured by acute and chronic changes in appetite using visual analogue scale questionnaires
3 secondary outcomes
Change in gut metabolites (from faecal samples) in response to dietary fibre
Time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)
Change in gut microbiome composition (from faecal samples) in response to dietary fibre
Time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)
Change in glycaemic control in response to dietary fibre
Time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)
Results and safety
The study was stopped early (reason given: There were issues with recruitment so study was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
Alexandra Johnstone, Prof principal investigator
Rowett Institute, University of Aberdeen
Alexander Ross, Dr principal investigator
Rowett Institute, University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 2 - High Fibre and Phase 3 - Low Fibre in people with Appetitive Behavior, 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 22 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: stopped early, as of the sponsor's last update on 10 May 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 was stopped early (reason given: There were issues with recruitment so study was stopped). Results are not available in the source record.
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?
Change in gut hormones to assess appetite response to dietary fibre (time frame: At baseline and end of each arm (study days 0, 14, 28 and 42)). 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 10 May 2024.