The effect of calorie-restriction along with thylakoid membranes of spinach on the gut-brain Axis Pathway and oxidative stress biomarkers in obese women with polycystic ovary syndrome: a Randomized, Double-blind, placebo-controlled clinical trial.
Study Goal
The researchers aimed to determine whether thylakoid membranes from spinach, combined with a hypocaloric diet, could improve LPS levels, neurotrophic factors, and oxidative stress in women with PCOS.
Results Summary
Thylakoid supplementation significantly reduced LPS levels and increased BDNF levels, while also improving glycemic and sex-hormone profiles. However, it had no significant effect on oxidative stress markers.
Population
48 women with obesity and PCOS diagnosed via Rotterdam criteria.
Effective Dosage
5 g/day thylakoid-rich spinach extract.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | LPS levels | women with obesity and diagnosed with PCOS | - | reduced | #1 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | increase | BDNF levels | women with obesity and diagnosed with PCOS | - | increased | #2 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | increase | glycemic profile | women with obesity and diagnosed with PCOS | - | improved | #3 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | increase | sex-hormone levels | women with obesity and diagnosed with PCOS | - | improved | #4 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | no change | OS markers levels | women with obesity and diagnosed with PCOS | - | had no effects on | #5 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | fasting blood glucose | women with obesity and diagnosed with PCOS | - | significant decreases were observed in | #6 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | insulin | women with obesity and diagnosed with PCOS | - | significant decreases were observed in | #7 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | homeostatic model of assessment for insulin resistance | women with obesity and diagnosed with PCOS | - | significant decreases were observed in | #8 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | free testosterone index | women with obesity and diagnosed with PCOS | - | significant decreases were observed in | #9 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | decrease | follicle-stimulating hormone / luteinizing hormone ratio | women with obesity and diagnosed with PCOS | - | significant decreases were observed in | #10 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | no change | malondialdehyde | women with obesity and diagnosed with PCOS | - | No significant differences were detected regarding the changes in | #11 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | no change | catalase | women with obesity and diagnosed with PCOS | - | No significant differences were detected regarding the changes in | #12 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | no change | total antioxidant capacity | women with obesity and diagnosed with PCOS | - | No significant differences were detected regarding the changes in | #13 |
thylakoid membranes of spinach supplementation along with a hypocaloric diet | no change | S100B levels | women with obesity and diagnosed with PCOS | - | No significant differences were detected regarding the changes in | #14 |
BACKGROUND: Women with polycystic ovary syndrome (PCOS) have higher intestinal mucosal permeability, leading to the lipopolysaccharide (LPS) leakage and endotoxemia. This, in turn, leads to oxidative stress (OS) and neuro-inflammation caused by the gut-brain axis, affecting the neurotrophic factors levels such as brain-derived neurotrophic factor (BDNF) and S100 calcium-binding protein B (S100 B) levels. In this study, it was hypothesized that the thylakoid membranes of spinach supplementation along with a hypocaloric diet may have improved the LPS levels, neurotrophic factors, and OS in PCOS patients. METHODS: In this double-blind, randomized, placebo-controlled, and clinical trial, 48 women with obesity and diagnosed with PCOS based on Rotterdam criteria were randomly assigned to thylakoid (N = 21) and placebo groups (N = 23). A personalized hypocaloric diet with 500 calories less than the total energy expenditure was prescribed to all patients. The participants were daily supplemented with either a 5 g/day thylakoid-rich spinach extract or a placebo (5 g cornstarch) for 12 weeks along with a prescribed low-calorie diet. Anthropometric measurements and biochemical parameters were assessed at baseline and after the 12-week intervention. RESULTS: A statistically significant decrease in the LPS levels (P < 0.001) and an increase in the BDNF levels (P < 0.001) were recorded for the participants receiving the oral thylakoid supplements and a low-calorie diet. Furthermore, significant decreases were observed in fasting blood glucose, insulin, homeostatic model of assessment for insulin resistance, free testosterone index, and follicle-stimulating hormone / luteinizing hormone ratio in both groups (P < 0.05). No significant differences were detected between the two groups regarding the changes in malondialdehyde, catalase, total antioxidant capacity, and S100B levels (P > 0.05). CONCLUSIONS: In sum, the thylakoid membranes of spinach supplemented with a hypocaloric diet reduced the LPS levels, increased the BDNF levels, and improved the glycemic profile and sex-hormone levels; however, they had no effects on the OS markers levels after 12 weeks of intervention.