Overweight and ObesityNCT06416254
The Fibre Full Study
A study testing Fibre-enriched diet in people with Overweight and Obesity, run by University College Cork at 1 site in Ireland.
Trial summary
This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Fibre-enriched diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- 28 Mar 2024to 7 Dec 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age
- Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I)
- Have had a stable body weight (≤5% change over the past three months)
- Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).
- Be willing to avoid consuming dietary supplements, prebiotics, probiotics, or fibre-rich supplements within four weeks prior to the baseline visit, and until the end of the study.
- Be willing to avoid physical exercise for the duration of the study (physical exercise defined as any physical activity that is planned to achieve a fitness goal)
- Be willing to consume the investigational products daily for the duration of the study.
Who cannot join
- Pregnant, lactating, menopausal or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months prior to baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include: anti-inflammatory drugs, H2 blockers, antacid, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, immunosuppressant medication. Participants should have a wash-out period of at least two-weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed onto the study if the dose has been stable for at least two months prior to the study baseline visit.
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of >2 alcoholic beverages/day (>28g ethanol daily).
- Follow a vegetarian or vegan diet
Show all 23Show fewer
- Have a typical fibre intake of >30g per day
- Have experienced major dietary changes within three months prior to the study baseline.
- Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
- Have a clinically diagnosed eating disorder.
- Have a food allergy or intolerance that would preclude study product intake (for example eggs, gluten, nuts, milk or any other food allergy or intolerance)
- Have an active gastrointestinal disorder or previous gastrointestinal surgery
- Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetes etc) or a significant history of such diseases.
- Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last 12 months).
- Have a malignant disease or concomitant end-stage organ disease.
- Have symptomatic respiratory or cardiac illness.
- Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months prior to baseline.
- Individuals who, in the opinion of the investigator are poor attendees or unlikely for any reason to be able to comply with the study protocol.
- Participants may not be receiving treatment involving experimental drugs.
- If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- Individuals with pacemakers or implantable cardioverter defibrillators.
- Individuals that regularly undertake rigorous exercise, defined by International Physical Activity Questionnaire with a score within category 3, Health Enhancing Physical Activity (HEPA) Active.
- Individuals who smoke or vape regularly (i.e., daily or habitual use).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response, Gastrointestinal Tolerability, Satiety, and Microbiome Functionality (The Fibre Full Study).
This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2).
Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet.
Read the detailed description
Participants: Healthy men and pre-menopausal, non-pregnant and non-lactating women, 18-45 years of age, with a Body Mass Index (BMI) between 25-34.9 kg/m2 will be recruited (n=20).
Study Design: This exploratory study aims to investigate the effects of a fibre-enriched (FR) diet in adults with excess body weight in comparison to a control diet. This randomized, single-blinded, placebo-controlled intervention/trial with a crossover design compares the effects of consumption of fibre-enriched food staples delivered within a full meal plan (fibre-enriched diet plan) with a matched control meal plan (control diet plan).
Participants stratified by age and BMI, will be randomly assigned to receive either the control diet or fibre-enriched (FR) diet for 8 days. After these 8 days, a washout period (13 day minimum) will commence, and participants will then crossover to the opposite diet. All foods and prepared meals within the menu plan will be provided to participants for both the control and FR diets. Participants are required to strictly adhere to their assigned meal plan for the 8-day period.
Given the higher dietary fibre intake of the FR-diet, the study design incorporates a dose escalation of the fibre content to allow participants on the FR diet to adjust to the increase in dietary fibre intake (4-day reduced dose, wherein study foods contain only a portion of the required dose of fibre, and 4-day full dose, high fibre intake).
The effect of the FR diet on satiety and overall food intake will be assessed. Participants on the FR diet and the control diet will be provided with non-fibre enriched snacks which they may consume at designated times each day, if they wish to and in ab libitum. These snacks will be an optional component of the menu plan. All food intakes will be monitored, and all leftovers will be returned to the research team. Additionally, dietary assessments will be completed at regular intervals.
Study Treatments:
- The FR diet consists of a full meal plan containing engineered common food products with decreased energy density and glycaemic index, in which a large proportion of refined carbohydrates are replaced with dietary fibre.
- The control diet consists of a full meal plan with non-fibre enriched food products.
Study Outcome measures will include post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (BMI 25-35kg/m2).
- Conditions
- Overweight and Obesity
- Being tested
- Fibre-enriched diet, Control diet
- Keywords
- Dietary fiber, glycemic control, gastrointestinal microbiome, microbiota, overweight, obesity, metabolism, satiety
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre-enriched dietOther
The fibre-enriched diet contains fibre-enriched foods in which a portion of digestible carbohydrates are replaced with isolated dietary fibres. The fibre-enriched study foods are consumed as part of a full meal plan provided to participants.
Control dietOther
The control diet contains non-fibre-enriched study foods. The control study foods are consumed as part of a full meal plan provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| Fibre-enriched | Active comparator | During the fibre-enriched arm, participants will receive the fibre-rich diet containing fibre-enriched foods provided through a full meal plan to be consumed throughout the day. Receives: Other: Fibre-enriched diet |
| Control | Placebo comparator | During the control arm, participants will receive a non-fibre enriched diet consisting of matched control foods provided through a full meal plan otherwise identical to the fibre-enriched arm. Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a fibre-enriched diet on glycaemic control
Changes in glycaemic response using continuous interstitial glucose monitoring when consuming the fibre-enriched diet compared to a matched control diet.
Measured: Assessments will be conducted continuously over each 8-day intervention period
Differences in participant reported satiety when consuming the fibre-enriched diet compared to the matched control diet
Differences in satiety assessed by analysis of Participant responses to the Satiety Labelled Intensity Magnitude (SLIM) scale and assessment of food consumption. The SLIM scale assesses perceived hunger/fullness using 11 phrases placed along a vertical line scale with "Greatest imaginable hunger" (score = -100) at the bottom and "Greatest imaginable fullness" at the top (score = +100).
Measured: Throughout each 8-day intervention period assessed at specific time points during the day (e.g. pre- and post-meal consumption)
Secondary outcomes (3)
Gastrointestinal tolerance to dietary fibre assessed by a Gastrointestinal Symptom and Bowel Movement Questionnaire
Evaluation of the impact of the fibre-enriched diet on gastrointestinal tolerance, through monitoring of participant reported gastrointestinal symptoms. This will be assessed via a Gastrointestinal Symptom and Bowel Movement Questionnaire comprising eleven questions from The Gastrointestinal Symptom Rating Scale (GSRS) followed by the Bristol Stool Chart and bowel frequency and flatus questions. The GSRS utilizes a 7-point response scale to measure the level of discomfort associated with a given gastrointestinal symptom, ranging from "No discomfort at all" to "Very severe discomfort." Participants will also rate the form of their stool sample using the Bristol Stool Chart.
Measured: Throughout each 8-day intervention period, assessed at specific time points (i.e. at baseline, 4 days (mid-point) and 8 days (end) of each dietary intervention)
Impact of a fibre-enriched diet on gut microbiota composition
Changes in gut microbiome composition and diversity between intervention periods through 16S ribosomal RNA (rRNA) gene sequencing of faecal samples.
Measured: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period.
Effect of a fibre-enriched diet on gut microbiota function
Changes in faecal metabolite concentrations determined through liquid chromatography-mass spectrometry (LC-MS)
Measured: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start28 Mar 2024
- Primary completion7 Dec 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Crossover
- Model description
- Crossover: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Walter, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416254
- Sponsor's protocol ID
- APC170
- Status last verified
- May 2026
- First submitted
- 3 May 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armet AM, Deehan EC, Thone JV, Hewko SJ, Walter J. The Effect of Isolated and Synthetic Dietary Fibers on Markers of Metabolic Diseases in Human Intervention Studies: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):420-438. doi: 10.1093/advances/nmz074.
PubMed 31342059Baenziger PS, Frels K, Greenspan S, Jones J, Lovegrove A, Rose D, Shewry P, Wallace R. A stealth health approach to dietary fibre. Nat Food. 2023 Jan;4(1):5-6. doi: 10.1038/s43016-022-00674-w. No abstract available.
PubMed 37118563David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PubMed 24336217Deehan EC, Walter J. The Fiber Gap and the Disappearing Gut Microbiome: Implications for Human Nutrition. Trends Endocrinol Metab. 2016 May;27(5):239-242. doi: 10.1016/j.tem.2016.03.001. Epub 2016 Apr 11.
PubMed 27079516Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
PubMed 31105044Ludwig DS, Ebbeling CB. The Carbohydrate-Insulin Model of Obesity: Beyond "Calories In, Calories Out". JAMA Intern Med. 2018 Aug 1;178(8):1098-1103. doi: 10.1001/jamainternmed.2018.2933.
PubMed 29971406Rouhani MH, Haghighatdoost F, Surkan PJ, Azadbakht L. Associations between dietary energy density and obesity: A systematic review and meta-analysis of observational studies. Nutrition. 2016 Oct;32(10):1037-47. doi: 10.1016/j.nut.2016.03.017. Epub 2016 Mar 31.
PubMed 27238958Sonnenburg ED, Sonnenburg JL. Starving our microbial self: the deleterious consequences of a diet deficient in microbiota-accessible carbohydrates. Cell Metab. 2014 Nov 4;20(5):779-786. doi: 10.1016/j.cmet.2014.07.003. Epub 2014 Aug 21.
PubMed 25156449Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
PubMed 26590418
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response, Gastrointestinal Tolerability, Satiety, and Microbiome Functionality (The Fibre Full Study).
- ClinicalTrials.gov ID
- NCT06416254
- Acronym / sponsor ID
- APC170
- Conditions
- Overweight and Obesity
- Keywords
- Dietary fiber, glycemic control, gastrointestinal microbiome, microbiota, overweight, obesity, metabolism, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 16 May 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 will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2).
Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet.
Detailed description
Participants: Healthy men and pre-menopausal, non-pregnant and non-lactating women, 18-45 years of age, with a Body Mass Index (BMI) between 25-34.9 kg/m2 will be recruited (n=20).
Study Design: This exploratory study aims to investigate the effects of a fibre-enriched (FR) diet in adults with excess body weight in comparison to a control diet. This randomized, single-blinded, placebo-controlled intervention/trial with a crossover design compares the effects of consumption of fibre-enriched food staples delivered within a full meal plan (fibre-enriched diet plan) with a matched control meal plan (control diet plan).
Participants stratified by age and BMI, will be randomly assigned to receive either the control diet or fibre-enriched (FR) diet for 8 days. After these 8 days, a washout period (13 day minimum) will commence, and participants will then crossover to the opposite diet. All foods and prepared meals within the menu plan will be provided to participants for both the control and FR diets. Participants are required to strictly adhere to their assigned meal plan for the 8-day period.
Given the higher dietary fibre intake of the FR-diet, the study design incorporates a dose escalation of the fibre content to allow participants on the FR diet to adjust to the increase in dietary fibre intake (4-day reduced dose, wherein study foods contain only a portion of the required dose of fibre, and 4-day full dose, high fibre intake).
The effect of the FR diet on satiety and overall food intake will be assessed. Participants on the FR diet and the control diet will be provided with non-fibre enriched snacks which they may consume at designated times each day, if they wish to and in ab libitum. These snacks will be an optional component of the menu plan. All food intakes will be monitored, and all leftovers will be returned to the research team. Additionally, dietary assessments will be completed at regular intervals.
Study Treatments:
- The FR diet consists of a full meal plan containing engineered common food products with decreased energy density and glycaemic index, in which a large proportion of refined carbohydrates are replaced with dietary fibre.
- The control diet consists of a full meal plan with non-fibre enriched food products.
Study Outcome measures will include post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (BMI 25-35kg/m2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.
| Arm | Type | Receives |
|---|---|---|
| Fibre-enriched | Active comparator | Other: Fibre-enriched dietDuring the fibre-enriched arm, participants will receive the fibre-rich diet containing fibre-enriched foods provided through a full meal plan to be consumed throughout the day. |
| Control | Placebo comparator | Other: Control dietDuring the control arm, participants will receive a non-fibre enriched diet consisting of matched control foods provided through a full meal plan otherwise identical to the fibre-enriched arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age
- Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I)
- Have had a stable body weight (≤5% change over the past three months)
- Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).
Key exclusion criteria (23 listed)
- Pregnant, lactating, menopausal or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months prior to baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include: anti-inflammatory drugs, H2 blockers, antacid, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, immunosuppressant medication. Participants should have a wash-out period of at least two-weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed onto the study if the dose has been stable for at least two months prior to the study baseline visit.
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of >2 alcoholic beverages/day (>28g ethanol daily).
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 |
|---|---|---|
| Fibre-enriched dietThe fibre-enriched diet contains fibre-enriched foods in which a portion of digestible carbohydrates are replaced with isolated dietary fibres. The fibre-enriched study foods are consumed as part of a full meal plan provided to participants. | Other | Fibre-enriched |
| Control dietThe control diet contains non-fibre-enriched study foods. The control study foods are consumed as part of a full meal plan provided to participants. | Other | Control |
Primary outcome
Impact of a fibre-enriched diet on glycaemic control
Time frame: Assessments will be conducted continuously over each 8-day intervention period
Changes in glycaemic response using continuous interstitial glucose monitoring when consuming the fibre-enriched diet compared to a matched control diet.
Differences in participant reported satiety when consuming the fibre-enriched diet compared to the matched control diet
Time frame: Throughout each 8-day intervention period assessed at specific time points during the day (e.g. pre- and post-meal consumption)
Differences in satiety assessed by analysis of Participant responses to the Satiety Labelled Intensity Magnitude (SLIM) scale and assessment of food consumption. The SLIM scale assesses perceived hunger/fullness using 11 phrases placed along a vertical line scale with "Greatest imaginable hunger" (score = -100) at the bottom and "Greatest imaginable fullness" at the top (score = +100).
3 secondary outcomes
Gastrointestinal tolerance to dietary fibre assessed by a Gastrointestinal Symptom and Bowel Movement Questionnaire
Time frame: Throughout each 8-day intervention period, assessed at specific time points (i.e. at baseline, 4 days (mid-point) and 8 days (end) of each dietary intervention)
Impact of a fibre-enriched diet on gut microbiota composition
Time frame: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period.
Effect of a fibre-enriched diet on gut microbiota function
Time frame: Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period.
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 7 May 2026.
- Background: PubMed 31342059Armet AM, Deehan EC, Thone JV, Hewko SJ, Walter J. The Effect of Isolated and Synthetic Dietary Fibers on Markers of Metabolic Diseases in Human Intervention Studies: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):420-438. doi: 10.1093/advances/nmz074.
- Background: PubMed 37118563Baenziger PS, Frels K, Greenspan S, Jones J, Lovegrove A, Rose D, Shewry P, Wallace R. A stealth health approach to dietary fibre. Nat Food. 2023 Jan;4(1):5-6. doi: 10.1038/s43016-022-00674-w. No abstract available.
- Background: PubMed 24336217David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Background: PubMed 27079516Deehan EC, Walter J. The Fiber Gap and the Disappearing Gut Microbiome: Implications for Human Nutrition. Trends Endocrinol Metab. 2016 May;27(5):239-242. doi: 10.1016/j.tem.2016.03.001. Epub 2016 Apr 11.
- Background: PubMed 31105044Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
- Background: PubMed 29971406Ludwig DS, Ebbeling CB. The Carbohydrate-Insulin Model of Obesity: Beyond "Calories In, Calories Out". JAMA Intern Med. 2018 Aug 1;178(8):1098-1103. doi: 10.1001/jamainternmed.2018.2933.
- Background: PubMed 27238958Rouhani MH, Haghighatdoost F, Surkan PJ, Azadbakht L. Associations between dietary energy density and obesity: A systematic review and meta-analysis of observational studies. Nutrition. 2016 Oct;32(10):1037-47. doi: 10.1016/j.nut.2016.03.017. Epub 2016 Mar 31.
- Background: PubMed 25156449Sonnenburg ED, Sonnenburg JL. Starving our microbial self: the deleterious consequences of a diet deficient in microbiota-accessible carbohydrates. Cell Metab. 2014 Nov 4;20(5):779-786. doi: 10.1016/j.cmet.2014.07.003. Epub 2014 Aug 21.
- Background: PubMed 26590418Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
- 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.
Jens Walter, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre-enriched diet in people with Overweight and Obesity, run by University College Cork at 1 site in Ireland.
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 8 inclusion and 23 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 7 May 2026. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Impact of a fibre-enriched diet on glycaemic control (time frame: Assessments will be conducted continuously over each 8-day intervention period). 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?
On the ClinicalTrials.gov record for NCT06416254, which also lists 9 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 7 May 2026.