Table 5.
Registered ongoing RCTs assessing the effects of the LFD on patients with IBD.
| Clinical Trial Identifier | Collaborators | Design | Intervention Duration | Sample | Intervention(s), Comparator(s) | Study Duration |
Primary Outcomes | Secondary Outcomes |
|---|---|---|---|---|---|---|---|---|
| NCT041 43633 * |
(1) Hospital General de México | Parallel, single-blind (patients) RCT | 10 weeks | (1) Patients with IBS; (2) Patients with UC; (3) Healthy participants (N = 105 normal weight or overweight adults) |
(1) LFD (55% CHO, 25% fat, 20% protein) in five meals daily (2) Standard diet (55% CHO, 25% fat, 20% protein) in five meals daily. Cruciferous vegetables, fruits, and condiments were eliminated and maintenance of a normal FODMAP content was sought |
February 2018 to August 2020 |
Nutritional status (serum TC, TG, Ca, Alb, Fe, Hb, Ht, vitamins B12 and D, and Cr levels) | (1) WHOQOL-BREF; (2) FFQ; (3) Body composition (BF, LBM) and anthropometry (arm, waist, and hips perimeters); (4) Gut microbiota (stool sample PCR); (5) Blood chemistry (Glu, Cr, HDL, LDL, TC); (6) IBS-SSS; (7) Symptoms severity |
| NCT024 69220 * |
(1) North Denmark Hospital (2) Vendsyssel Hospital |
Parallel RCT with quadruple masking | 8 weeks | Patients with UC and IBS (N = 45 adults) | (1) LFD and low-FODMAP ONS; (2) LFD and high-FODMAP ONS; |
June 2015 to December 2020 |
IBS-SSS | (1) SF36 (2) Pain (VAS) |
| NCT036 44602 † |
(1) Shariati Hospital (2) Tehran University of Medical Sciences |
Parallel, open-label RCT | 4 weeks | Patients with moderate UC (N = 32 adults) | (1) LFD (55% CHO, 25% fat, 20% protein) in six meals daily; (2) Standard UC care including PA advice, intake of low-fat dairy and meat, intake of vegetable oils and reduced refined sugars |
July 2018 to April 2023 |
(1) Gut microbiota (via PCR) | (1) Inflammation (NOD, via ELISA) |
Alb, albumin; BMR, basal metabolic rate; BF, body fat; BW, body weight; Ca, calcium; CHO, carbohydrate; Cr, creatinine; ELISA, enzyme-linked immunosorbent assay; Fe, iron; FFQ, food frequency questionnaires; FODMAP, Fermentable Oligo-, Di-, Monosaccharides, and Polyols; Glu, glucose; Hb, hemoglobin; HDL, high-density lipoprotein; Ht, hematocrit; IBD, inflammatory bowel disease; IBS, irritable bowel syndrome; IBS-SSS, IBS Severity Scoring System [49]; LBM, lean body mass; LDL, low-density lipoprotein; LFD, low-FODMAP diet; NCT, National Clinical Trials (Clinicaltrials.gov); NOD, not other defined; ONS, oral nutrient supplement; PA, physical activity; PCR, polymerase chain reaction; RCT, randomized controlled trial; SF36, Short-form 36 [42]; TC, total cholesterol; TG, triglycerides; UC, ulcerative colitis; VAS, Visual Analog Scale; WHOQOL-BREF, World Health Organization Quality of Life questionnaire; † Recruitment status completed; * Recruitment status ongoing.