The Fibre Full Study

NCT06416254 | Recruiting

• 1 other identifier: APC170
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Overweight and Obesity

Keywords

Dietary fiber; glycemic control; gastrointestinal microbiome; microbiota; overweight; obesity; metabolism; satiety

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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

  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

  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

  Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period.

Other Outcomes (1)

• Impact of a fibre-enriched diet on gut inflammatory marker concentration.

  Assessments may be conducted at baseline (pre-intervention), and then at the end of each 8 day intervention period.

Study Arms (2)

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.

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.

Other: Control diet

Interventions

Fibre-enriched diet OTHER

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.

Fibre-enriched

Control diet OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: An equal number of male and female participants will be enrolled
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

RECRUITING

Related Publications (9)

• 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.

  PMID: 31342059 BACKGROUND

• 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.

  PMID: 37118563 BACKGROUND

• 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.

  PMID: 24336217 BACKGROUND

• 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.

  PMID: 27079516 BACKGROUND

• 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.

  PMID: 31105044 BACKGROUND

• 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.

  PMID: 29971406 BACKGROUND

• 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.

  PMID: 27238958 BACKGROUND

• 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.

  PMID: 25156449 BACKGROUND

• 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.

  PMID: 26590418 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Walter, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

086 199 2919; fibrestudy@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: March 28, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)