Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of a fibre-enriched diet on gut inflammatory marker concentration. | Changes in gut inflammatory marker concentration using established methods. | Assessments may be conducted at baseline (pre-intervention), and then at the end of each 8 day intervention period. |
Inclusion Criteria:
Exclusion Criteria:
An equal number of male and female participants will be enrolled
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Walter, PhD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Cork | Cork | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31342059 | Background | 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. | |
| 37118563 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| 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. |
|
| 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. | 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) | Assessments may be conducted at baseline (pre-intervention), and then at 4 days (mid-point) and 8 days (end) of each study intervention period. |
| 24336217 | 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. |
| 27079516 | 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. |
| 31105044 | 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. |
| 29971406 | 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. |
| 27238958 | 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. |
| 25156449 | 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. |
| 26590418 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |