Impact of a Formulation Containing Unusual Polyunsaturated Fatty Acids, Trace Elements, Polyphenols and Plant Sterols on Insulin Resistance and Associated Disturbances

María J Peláez-Jaramillo, Natalia Valencia-Enciso, Allison A Cárdenas-Mojica, Paula V Gaete, Eitan A Scher-Nemirovsky, Luisa F Gómez-Arango, Daniel Colmenares-Araque, Camilo A Castro-López, Eddy Betancourt-Villamizar, Jesús Jaimes-Madrigal, Carlos A Alvarez, Mario A Jiménez-Mora, Pedro J Quiroga-Padilla, Danna K Puerto-Baracaldo, Carlos O Mendivil, María J Peláez-Jaramillo, Natalia Valencia-Enciso, Allison A Cárdenas-Mojica, Paula V Gaete, Eitan A Scher-Nemirovsky, Luisa F Gómez-Arango, Daniel Colmenares-Araque, Camilo A Castro-López, Eddy Betancourt-Villamizar, Jesús Jaimes-Madrigal, Carlos A Alvarez, Mario A Jiménez-Mora, Pedro J Quiroga-Padilla, Danna K Puerto-Baracaldo, Carlos O Mendivil

Abstract

Introduction: To evaluate the effect of a lipid-based formulation containing unusual polyunsaturated fatty acids, trace elements, polyphenols and plant sterols on insulin resistance and its associated disturbances among adults at risk of diabetes.

Methods: This was an 8-week, three-arm, open-label randomized clinical trial. We studied individuals aged ≥ 18 years old with diabetes risk given by a body mass index ≥ 25 kg/m2 or a FinnRisc score ≥ 13/20. Participants were randomly assigned to receive: 7 ml sunflower oil (control group), 3.5 ml of the study formulation + 3.5 ml of sunflower oil (low-dose group) or 7 ml of study formulation (high-dose group).

Results: We randomized 25 individuals. After one withdrawal in the high-dose group, the study sample comprised nine patients in the control, nine in the low-dose and six in the high-dose groups. The insulin sensitivity increased significantly and in a dose-dependent fashion, up to 10% in the high-dose group. At week 8 the low-dose group exhibited lower glycemic excursions during the oral glucose tolerance test (OGTT), especially 1 h after the glucose challenge (32 mg/dl or 23% lower vs. control group). The incremental area under the glucose curve in the OGTT was 17.1% lower in the low-dose group vs. the control group. Waist circumference increased in the control group, remained constant in the low-dose group and decreased in the high-dose group. C-reactive protein decreased in both formulation groups, up to 50% in the high-dose group. Participants in the formulation groups exhibited increased secretion of GLP-1 and plasma irisin at week 8 vs. the control group.

Conclusion: The formulation induced favorable changes in insulin sensitivity, glucose tolerance, abdominal obesity and inflammation. These effects and their durability will need to be assessed in larger studies.

Trial registration: NCT03512665.

Funding: Team Foods Colombia.

Keywords: Adipokines; Diabetes; Fatty acids; Gastrointestinal hormones; Insulin resistance; Metabolic syndrome.

Figures

Fig. 1
Fig. 1
Change in the insulin sensitivity index by treatment group
Fig. 2
Fig. 2
Glycemic excursions during the oral glucose tolerance test (OGTT) by treatment group
Fig. 3
Fig. 3
Change in glycated hemoglobin and lipid risk factors (week 8–week 0) by treatment group. a Change in HbA1c; b change in plasma triglycerides; c change in plasma HDL cholesterol; d change in plasma LDL cholesterol. Data are mean ± SD
Fig. 4
Fig. 4
Change in liver enzymes and C-reactive protein by treatment group. a Change in aspartate amino transferase (AST); b change in alanine amino transferase (ALT); c change in gamma-glutamyl transpeptidase (GGT); d change in C-reactive protein. Data are mean ± SD
Fig. 5
Fig. 5
Changes in gastrointestinal hormone response to a glucose load in OGTT by treatment group. a Mean percent change in suppression of ghrelin secretion (120 min plasma ghrelin-fasting plasma ghrelin); b mean percent change in secretion of glucagon-like peptide (GLP-1) (120 min plasma GLP-1—fasting plasma GLP-1)
Fig. 6
Fig. 6
Box plot of changes in plasma myokines by treatment group. a Percent change in plasma fibroblast growth factor-21 (FGF-21); b percent change in plasma irisin

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Source: PubMed

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