A double blind, placebo controlled randomized clinical trial investigated the impact of low FODMAP diets with vs without gluten on IBS symptoms. The aim of the study was to determine which wheat constituent, fructans or gluten, is the culprit for triggering IBS symptoms. All participants consumed a low FODMAP diet for six weeks, with the intervention group (n = 26) also taking 5g/day of gluten powder and the control group (n = 23) 5g/day of rice flour. The primary outcome was a significant reduction in symptoms, measured using the IBS Severity Scoring System (IBS-SSS). Symptoms included abdominal pain intensity and frequency, abdominal distention, bowel habits satisfaction, interference with community function, and stool consistency and frequency. Quality of life was measured as a secondary outcome using the IBS QOL questionnaire. Results showed significant improvements in total IBS-SSS scores and clinical symptoms in both groups, with the placebo experiencing a higher improvement in stool frequency and consistency compared to the intervention. Symptoms worsened in 5 participants on gluten supplementation, which could confirm the concept of non-celiac gluten sensitivity being present in some IBS patients. It may be interpreted that wheat and barley exaggerate IBS symptoms mainly through their fructan content, with gluten only being the responsible culprit in a small percentage of IBS patients.

Heart disease is the number one cause of death in the United States and the second most prevalent cause of death in Canada. The 12-month trial recruited workers aged 25 to 65 years, with a current primary care physician from three Canada Post Corporation worksites (Edmonton, Toronto, and Vancouver). Participants were first screened for CVD risk using the Framingham Score then randomized to either enhanced usual care (EUC: three 1-hour biometric screening and data collection visits) or naturopathic care plus EUC (NC+EUC; the above plus an individualized mix of lifestyle counselling and nutritional and botanical medicine offered during the data collection visits plus up to four additional 30-minute visits over the year). Both groups received care in an on-site clinic from licensed naturopathic doctors and were asked to continue to see their family physician as needed for their general health care needs. Medical claims and sick leave data were also accessed. In total, 156 subjects (77 EUC, 79 NC+EUC) participated. In the NC+EUC group, cardiovascular disease event risk over the next 10 years was reduced by 3.3% and CVD mortality risk by 0.9%. While, the naturopathic intervention was more expensive, statin drugs alone cost more. The impact of naturopathic care on the NC+EUC group saw more presenteeism. This trial demonstrates that a naturopathic approach to the primary prevention of CVD has the potential to significantly reduce CVD risk for those with a wide range of baseline risk.

In a randomized control trial conducted by the Department of Acupuncture of SDM College of Naturopathy and Yogic Sciences in Karnataka, India, 60 participants aged 17-23 years old were recruited from a residential college. Inclusion criteria: history of primary dysmenorrhea for at least 1 year; regular menstruation with periods from 21-35 days; no history of oral contraceptive use, intrauterine device, or any medicine for dysmenorrhea for the past 6 months. Participants received clinical acupuncture on the 6th day of the period in the TCM style for symptomatic relief of dysmenorrhea at 12 acupuncture points: KI-3, SP-8, ST-25, ST-29, ST-30, ST-36, CV-4, CV-6, BL-62, HT-7, LI-4, and PC-6. Needles used were 0.2 x 30mm stainless steel. Each participant received a total of 45 sessions of acupuncture (1 session for 20 minutes/day, 15 sessions/30 days, for the period of 90 days) by a physician with more than 15 years of experience in clinical acupuncture. Outcomes were measured on numerical scales: pain intensity from 0-10 (1-3 = mild pain, 4-7 = moderate pain, 8-10 = severe pain); muscle cramping from 0-3 (3 = severe); systemic symptoms from 0-3 (3 = symptoms exist severely/are debilitating). Baselines were taken on the 1st, 30th, 60th and 90th days. The control group received no treatment. The study group showed a significant reduction in all variables except faint and headache, especially during the 30th and 60th days and upon post intervention assessment. 

A double-blind, placebo-controlled study was conducted to study the effectiveness of the specific bioactive collagen peptide (BCP) powder VERISOL® on eye wrinkle formation and stimulation of procollagen I, elastin and fibrillin biosynthesis in the skin. 114 women aged 45-65 years were randomized to receive 2.5 g of BCP or placebo (maltodextrin powder), once daily for 8 weeks, with 57 subjects being allocated to each treatment group. The products were taken orally by the subjects at home according to the instructions given by the investigator. The powder was to be dissolved in water or any other liquid. Subjects were prohibited from using skincare products, suntanning, saunas, making lifestyle changes, etc. Skin wrinkles were objectively measured in all subjects, before starting the treatment, after 4 and 8 weeks as well as 4 weeks after the last intake (4-week regression phase). The BCP group showed a statistically significant reduction of eye wrinkle volume (p <0.05) in comparison to the placebo group after 4 and 8 weeks (20%) of intake and a long-lasting effect after 4 and 8 weeks of discontinuing treatment, including a 65% increase in pro collagen type I, an 18% increase in elastin and a 6% increase in fibrillin.

Evidence has emerged supporting the antidepressant-like effect of foods with high flavonoid content, like fruits, vegetables, and various beverages. Literature searches from PubMed, Scopus, and Web of Science found 36 clinical trials to include in the meta-analysis and 10 observational cohort studies for the systematic review. Most studies were randomized, blinded, and included male and female participants aged > 40. Most of the trials tested the clinical effects of flavonoids consumed as tablets, pills, powders, or liquids. The meta-analysis revealed a statistically significant reduction in depressive symptoms in participants (n = 2788) following consumption of dietary flavonoids, specifically from the flavonoid subclasses isoflavones, flavonols, and flavan3-ols. Of the 10 observational studies included in the systematic review, 5 suggested a diet higher in flavonoids could improve symptoms of depression. Authors performed a quality assessment of all studies and trials before they were included in the current study and evaluated publication bias using a funnel plot and Egger’s test. Authors concluded that while there is evidence to support flavonoids as beneficial for depressive symptoms, more research is required to evaluate them as a dietary prevention measure specifically against symptoms of Major Depressive Disorder.

A randomized, double-blind, placebo-controlled, multi-dose trial investigated the effect of saffron extract on sleep quality, cortisol, and melatonin concentrations in adults with unsatisfactory sleep. The 28-day trial randomly allocated 120 participants with self-reported sleep problems to three groups, each being instructed to take a different dose of either 14 mg or 28 mg of saffron, or a comparable placebo 1 hour before bed. The primary outcome measured was sleep quality, evaluated using the Pittsburgh Sleep Diary (PSD). Additional sleep questionnaires included: (1) the Insomnia Symptom Questionnaire, (2) Profile of Mood States, to measure participant’s moods upon waking, (3) Functional Outcomes of Sleep Questionnaire, to evaluate QOL as it relates to sleep, and (4) the Restorative Sleep Questionnaire. Researchers also measured salivary melatonin and cortisol at baseline and on day 28, finding a significant increase in melatonin and decrease in cortisol in both saffron groups, with no comparable changes in placebo. Results also found a significant difference in sleep quality between saffron and the placebo based on the PSD, with significant increases of 24.60% in saffron 14 mg and 22.26% in saffron 28 mg, and a non-significant increase of 8.43% in the placebo group. Additional findings included improved mood upon wakening and reduced rates of insomnia in the saffron groups.

The aim of this study was to assess whether non-heme iron absorption was promoted by the simultaneous intake of Lactobacillus plantarum 299v (9 or 10 billion CFU). The 21 study participants - healthy women of reproductive age - were given a fruit drink with iron isotopes that were labelled and then measured with whole body counting and in blood. The study was separated into 2 trials: Trial 1 compared an iron control drink with a drink that contained iron and 9 billion CFU; while trial 2 compared the control iron drink with one that contained iron and 10 billion CFU. The result of the study demonstrates that L. plantarum 299v enhances iron absorption when administered together. Specifically, when combining the results of both trials the mean iron absorption with the added L. plantarum 299v was significantly higher than the control drink iron absorption (p<0.004). Trials 1 and 2 did not differ significantly (p<0.941) nor did the iron absorption from the two control drinks in trials 1 and 2 (P<0.557).

An open-label randomized controlled clinical trial investigated Nigella sativa oil (NSO) – a herbal extract with anti-inflammatory, immunomodulatory, and antiviral properties – as an effective treatment for COVID-19. Eligible participants aged 18 and above presented with mild symptoms of COVID-19 between May 1 and Sept. 31, 2020, at the King Abdulaziz University Hospital in Jeddah, Saudi Arabia. Cases were confirmed using the polymerase chain reaction test within 1 week of symptom onset. Participants were randomly allocated to the intervention group (n=91) to receive 500 mg NSO twice daily for 10 days with standard care, or the control group (n=92) to receive only standard care. The primary outcome was the percentage of patients who reported being 3 days symptom-free within 14 days following randomization. Authors assessed the number of days for recovery, adverse drug reactions, symptom duration, and disease-related hospital admissions as secondary outcomes. A total of 183 participants were included in quantitative statistical analysis. Results indicated a significant relationship between NSO and a higher likelihood for recovery from mild COVID-19, where nearly 62% of participants in the intervention group achieved symptom-free recovery by day 14, compared to only 36% in the control group. Treatment with NSO was also reported to lower adverse effects, shorten recovery time by 2 days, and impact the duration of anosmia (loss of smell) and runny nose symptoms in patients.

A randomized, placebo-controlled, crossover trial investigated whether coadministration of psyllium with inulin – a dietary fibre – could reduce gastrointestinal symptoms in IBS patients. A total of 19 participants with either constipation- or diarrhea-predominant IBS were instructed to consume a low-fibre, low-FODMAP diet one day prior to the study to limit food intake that might increase colonic gas. Participants were administered a one-time 500 mL test drink containing either (1) 20 g inulin, (2) 20 g psyllium, (3) 20 g inulin and psyllium, or (4) 20 g dextrose powder to be used as a placebo control. Colonic gas was measured with hourly MRI scans for the 6-hour period. Authors also measured breath hydrogen every 30 minutes and collected stool samples to test for fermentation and viscosity in a separate in vitro study on laboratory models. Inulin was found to cause the highest rise of median colonic gas (3145 mL) in the 6-hour timeframe, compared to the significant reduction when inulin and psyllium were co-administered (618 mL). Breath hydrogen significantly increased from 120 min with inulin but not psyllium administration, while co-administration reduced and delayed an increase. Fermentation results from the in vitro study reported higher gas production with inulin alone compared to the psyllium-inulin combination, suggesting that psyllium coadministration with inulin can reduce inulin-related gas production in IBS patients. 

A 12-week randomized, double-blind controlled trial conducted in Hong Kong investigated the effect of berberine supplementation on cardiovascular disease (CVD) risk factors and testosterone in men. Berberine, an isoquinoline plant alkaloid, possesses strong anti-lipidemic, anti-inflammatory, and cardioprotective properties, with previous literature suggesting its use for managing symptoms of CVD. Authors recruited male volunteers aged 20 to 65 years with hyperlipidemia, defined by (1) triglyceride levels > 150 mg / dl, (2) total cholesterol > 200 mg / dl, and/or (3) LDL cholesterol > 100 mg /dL. Participants were randomly allocated to receive the intervention – purified 500 mg berberine tablets – or a similar placebo material, both supplemented orally twice daily for the study duration. Primary outcomes measured included: lipids, triglycerides, HDL cholesterol, thromboxane A2, systolic and diastolic blood pressure, and serum testosterone, with body mass index (BMI) and waist-hip ratio (WHR) included as secondary outcomes. Researchers used an analysis of variance and generalized estimating equation (GEE) to assess differences between the berberine (n = 40) and placebo (n = 40) group at weeks 8 and 12. Study results were consistent with current evidence, showing a statistically significant lowering effect of berberine on total cholesterol (p = 0.0001) and perhaps also LDL cholesterol (p = 0.03). Other key findings include a null effect of berberine on thromboxane A2 and a possible increase in testosterone in men (p = 0.01). This study suggests that berberine might safely lower cholesterol and could influence specific sex hormones in men.

A 16-week randomized controlled trial investigated the effect of green tea extract (GTE) intake on the neurophysiological and clinical condition of patients with mild-to-moderate diabetic neuropathy. The biochemical compounds found in green tea (Camellia sinensis) hold anti-inflammatory, hypolipidemic and antioxidant properties, with supplementation suggested to help with the sensory symptoms of peripheral neuropathy. The study included 194 participants diagnosed with diabetic neuropathy with symptoms classified as mild (6-8 points) or moderate (9-11 points) using the Toronto Clinical Scoring System (TCSS). Researchers measured participants at baseline and 4-week intervals using the visual analogue scale (VAS) for sensorineural pain and vibration perception thresholds (VPT) for neural dysfunction. Participants in the intervention group (n = 96) consumed decaffeinated 500 mg GTE capsules 30 minutes after meals 3 times daily for 16 weeks, and participants in the control group (n = 98) received a comparable placebo material for the same duration. Quantitative analysis revealed significant improvement in symptoms following GTE supplementation, showing lower VAS, TCSS and VPT scores after 8 weeks of treatment compared to baseline. This difference became more evident at 16 weeks, indicating a beneficial effect of GTE in reducing sensorineural symptoms for patients with mild-to-moderate diabetic neuropathy.

Older people tend to have lower nitric oxide production, associated with poorer vascular and cognitive health. In a study by the University of Exeter, 26 healthy older people (70s to 80s) took part in two ten-day supplementation periods: one with nitrate-rich beetroot juice and another with nitrate-free placebo juice, which they drank twice a day. Participants were healthy, active older people with generally good blood pressure. Beetroot (as well as lettuce, spinach, and celery) are rich in inorganic nitrate, and many oral bacteria play a role in turning nitrate to nitric oxide, which helps to regulate blood vessels and neurotransmission (chemical messages in the brain). After the supplementation period, the results showed higher levels of oral bacteria associated with good vascular and cognitive health, and lower levels of bacteria linked to disease and inflammation. Also, systolic blood pressure dropped on average by five points (mmHg) after drinking the beetroot juice.

The study was conducted towards 60 participants aged 20-40 years with mild to moderate acne. Herbal extracts used for the intervention included: mangosteen, Lithospermum officinale, Tribulus terrestris L., and Houttunynia cordata Thunb extract. Participants were blinded and randomly allocated to the intervention or control group and followed instruction to use the cleanser containing the herbal extracts twice per day every morning and evening. Researchers assessed efficacy and safety profiles of the intervention using acne inflammatory and non-inflammatory lesion counts and a skin biopsy. Results showed a significant decrease in both lesion types in the intervention group at week 8, with a 56% reduction in inflammatory lesions (p = 0.005) and a 36% reduction in non-inflammatory lesions (p = 0.028). A total of 9 mild adverse effects were reported from participants who experienced either dryness, burning, or prickling sensations following application of the herbal extracts. Immunohistochemistry also revealed a significant decrease in the expression of mediators IL-1a, IL-8 and keratin 6, which are responsible for inflammation and abnormal follicular keratinization in acne lesions. Researchers concluded herbal extracts as having significant clinical efficacy in treating patients with mild to moderate acne.

There is a worldwide increase in the prevalence and incidence of ulcerative colitis (UC) with a lack of adequate treatment for many of these patients. Bilberries (Vaccinium myrtillus or “European blueberries”) possess a naturally high content of anthocyanins (50–80%). Anthocyanins are potential therapeutic agents in gastrointestinal (GI) diseases including UC because of their anti-oxidative and anti-inflammatory properties. An open, prospective, non-blinded, non-controlled pilot trial was conducted for 7 weeks among 13 mild-to-moderate UC patients at the University Hospital Zurich. Inclusion criteria comprised an established diagnosis of mild-to-moderate UC for at least 6-months, an age range between 18 and 65 years old, and a stable use of medication with stable doses for at least 3 months and 4 weeks. During week 1, a full medical history, physical examination, a lab screen, urine analyses and a sigmoidoscopy were obtained. Also, the clinical activity index (CAI) and the complete Mayo Score were determined, the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was completed, and a patient diary was given. Bilberry intake began at week 2 and ended at the week 7 visit. Patients received a daily bilberry dose of 4 trays of 160 g. Remission was 54.5% at the end of 7 weeks. The response rate was 90.9% at end of treatment and 72.7% at end of study. There was a significant reduction in the complete Mayo Score of at least two points in all patients. In 81.8% of patients, the SIBDQ score was significantly higher at end of treatment as compared to screening. Fully blinded examination of biopsy specimen from the rectum and sigmoid colon in random order revealed a decline in acute inflammatory changes, however, these changes did not reach statistical significance (p = 0.17).

In a meta-analysis 15 RCT’s were included examining the peri-operative care of colorectal cancer patients. The most used probiotic species included Lactobacilli (L. acidophilus, L. plantarum) and Bifidobacteria (B. longum) There was a trend towards lower rates of post-operative infectious and non-infectious complications with probiotics vs. placebo. Administration of probiotics also reduced bacterial translocation, maintained intestinal mucosal permeability, and resulted in better balance of beneficial to pathogenic microorganisms. Therefore, the administration of peri-operative probiotics could possibly minimize the risk of post-operative complications.