Seventy-one healthy subjects with sleep disturbances participated in a randomized, double-blind controlled trial in which dietary supplementation with an extract of Aloysia citrodora (lemon verbena) (n = 33) or placebo (n = 38) was administered for 90 days. There were between-group differences in favor of the experimental group in the visual analogue scale (VAS) for sleep quality (6.5 ± 1.6 vs. 5.5 ± 2.1, p = 0.021) as well as in the overall score (5.8 ± 2.4, p = 0.008) and scores for sleep latency (1.6 ± 1.0 vs. 1.9 ± 0.7, p = 0.027) and sleep efficiency (84.5 ± 12.8 vs. 79.8 ± 13.6, p = 0.023) in the Pittsburgh Sleep Quality Index (PSQI). Sleep-related variables (latency, efficiency, wakefulness after sleep onset, awakenings) assessed by actigraphy also showed better scores in the experimental group (p = 0.001). Plasma nocturnal melatonin levels also increased significantly in the experimental group (199.7 ± 135.3 vs. 174.7 ± 115.4 pg/mL, p = 0.048). Changes in anthropometric parameters and physical activity levels were not found. In summary, a dietary supplement of lemon verbena administered for 3 months was associated with a significant improvement in sleep quality as compared with placebo in a population of healthy subjects with sleep problems.

A randomized, double-blind and controlled study was conducted to assess the effectiveness of the intake of 250 mL of lactose-free skimmed milk enriched with ashwagandha (Withania somnifera) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sleep problems. The duration of supplementation was 90 days. Fifty-two eligible subjects were assigned to the study arms of ashwagandha 250 mg, ashwagandha 250 mg plus tryptophan 175 mg, ashwagandha 600 mg, and control with 13 subjects in each group. It was hypothesized that ashwagandha plus tryptophan could be superior to ashwagandha alone for improving sleep-related variables. Changes in the visual analogue scale (VAS) for sleep quality were significantly higher in the three experimental groups as compared with controls (p = 0.014). Improvements in the subscales of the Pittsburg Sleep Quality Index (PSQI) were found in all groups, but between-group differences were not significant. In the index of insomnia severity, decreases were higher in the three experimental groups as compared with controls especially in the group of ashwagandha 600 mg. Daytime somnolence was also reduced in the three experimental groups. Changes in anxiety levels and Morningness–Eveningness Questionnaire were not observed. The study products did not elicit changes in body composition and were well tolerated and safe. The data did not support the hypothesis, as the combination of ashwagandha and tryptophan did not show greater benefits in improving sleep quality than ashwagandha alone. However, the results from the three experimental groups containing ashwagandha were more favorable compared to the placebo group.

A single-center, randomized, double-blind, and placebo-controlled clinical trial assessed the efficacy in improving body composition and in weight management of a dietary supplement consisting of 400 mg of a standardized extract of the persimmon fruit (Diospyros kaki L.f.) in adult subjects with a BMI between 25 and 34.99 kg/m² administered for 120 consecutive days. In total, 36 participants were assigned to the placebo group and 35 to the experimental group (registered at ClinicalTrials.gov (NCT05750342)). Primary analysis focused on overweight subjects (placebo, n = 26; experimental, n = 23). In this group, fat mass expressed in kg and percentage evaluated by both dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA) decreased significantly (between-group differences p < 0.001) in those receiving the persimmon extract as compared with the placebo. No significant reduction in lean mass was observed, suggesting that the muscle mass was maintained during fat loss. The use of the investigational product improved classic anthropometric parameters to a statistically significantly greater extent than the placebo, including body weight, BMI, and waist and abdominal circumference (p < 0.001), in the overweight group. In the overall population, similar improvements were observed, with significant between-group differences (p < 0.001) in fat mass reduction and improvements in body composition. Changes in the biochemical lipidic, glycemic, and anti-inflammatory profile were not found, except for between-group significant differences (p < 0.001) in decreases in tumor necrosis factor-alpha (TNFα) and increases in total antioxidant capacity (TAC) in favor of the experimental condition. There was a significant increase in fecal fat excretion in the experimental group at the end of the study in subjects with low fecal fat (9%) at baseline. Consumption of the investigational product vs. placebo improved the quality of life, with significantly greater scores in the total score and the mental health component of the SF-12 questionnaire. The persimmon extract was safe and well tolerated.

A single-center, randomized, double-blind, placebo-controlled clinical trial with two arms was conducted in 71 healthy subjects suffering from sleep disturbances, which were treated with a dietary supplement based on an extract of Aloysia citrodora (or Lippia citriodora, lemon verbena) (n = 33) for 90 days. Subjects in the placebo group (n = 38) received capsules of microcrystalline and maltodextrin with the same organoleptic properties. Between-group significant differences in favor of the experimental group were found in the visual analogue scale (VAS) score rating sleep quality; overall score, sleep latency and sleep efficiency of the Pittsburg Sleep Quality Index (PSQI); and sleep latency, sleep efficiency, wakefulness after sleep onset and duration of awakening assessed by actigraphy. Plasma nocturnal melatonin levels also increased significantly in the experimental group. Changes in anthropometric parameters and physical activity levels were not found. This study shows that the administration of a dietary supplement comprised lemon verbena administered for 3 months was associated with a significant improvement of sleep quality as compared with placebo in a population of healthy subjects with sleep problems. Improvements were also apparent at the mid-study visit after 45 days of supplementation.

Background/Objectives: A 90-day randomized double-blind and placebo-controlled study was conducted to assess the effect of carob (Ceratonia siliqua L.) on glucose metabolism in subjects with confirmed prediabetes. Methods: The carob liquid concentrate containing inositols of the carob fruit (D-pinitol, myo-inositol, D-chiro inositol) was administered at a daily dose of 6.66 g, divided into two doses of 3.33 g each. Study variables included glucose- and insulin-related parameters obtained at fasting conditions and during a standard 2 h oral glucose tolerance test (OGTT) at baseline and after 45 and 90 days of administration of the study products. Results: The study population included 52 subjects (25 in the experimental group, 27 in the placebo group), 27 men and 25 women, with a mean age of 45.6 ± 13.9 years. Subjects who consumed the active product showed improvements in glycated hemoglobin (HbA1c) and glucose levels as compared with placebo (p < 0.001 of the time × group interaction). Fasting serum insulin showed within-group significant decreases in the experimental group, with insulin indexes (HOMA-IR and QUICKI) improving significantly in the experimental group only. In the OGTT, there were significant improvements in the AUC of glucose and insulin, as well as glucose peak in the experimental group only. The product was well tolerated and no adverse effects were recorded. Conclusions: The use of a specific carob-based liquid concentrate decreased HbA1c and glucose levels in subjects with prediabetes, which may suggest its potential clinical relevance in the prevention of the transition from prediabetes to overt type 2 diabetes.