Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-03-28
2025-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Fibre-enriched
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.
Fibre-enriched diet
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
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.
Control diet
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.
Interventions
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Fibre-enriched diet
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 diet
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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).
18 Years
45 Years
ALL
Yes
Sponsors
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University College Cork
OTHER
Responsible Party
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Principal Investigators
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Jens Walter, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Locations
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University College Cork
Cork, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Baenziger 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.
David 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.
Deehan 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.
Hall 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.
Ludwig 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.
Rouhani 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.
Sonnenburg 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.
Zeevi 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.
Other Identifiers
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APC170
Identifier Type: -
Identifier Source: org_study_id
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