Marleigh Smith, Susanne Mitschke, Alice van der Schoot
These findings suggest that this novel multinutrient supplement may be of interest as a nutritional approach to support females throughout the menstrual cycle, warranting further investigation in randomized, placebo-controlled trials.This trial was registered on clinicaltrials.gov as NCT07267728.
BACKGROUND: Premenstrual and menstrual symptoms arise in response to cyclical hormonal fluctuations and encompass psychological and physical manifestations that may significantly impair quality of life. Treatment options are limited, demonstrate inconsistent efficacy, and are associated with notable adverse effects. There is growing interest in evidence-based nutritional approaches, with several placebo-controlled trials demonstrating that certain nutrient supplements significantly alleviate menstrual-cycle-related symptomatology.
OBJECTIVES: This single-arm pilot study aims to evaluate self-reported changes in premenstrual and menstrual symptoms in females taking a novel multinutrient supplement containing saffron extract, chamomile extract, essential minerals (chromium, magnesium, zinc, iron), vitamins (D, B6, C), and- omega-3 (n-3) fatty acids, using advanced encapsulation technology.
METHODS: Forty females (mean age: 33 y) with premenstrual and menstrual symptoms consumed the supplement daily for 3 consecutive menstrual cycles. The validated Menstrual Symptom Questionnaire (MSQ) and a 5-point severity rating scale evaluated symptoms at baseline and after each menstrual cycle.
RESULTS: Overall MSQ scores decreased significantly from baseline to cycle 1 (P = 0.0028), cycle 2 (P < 0.0001), and cycle 3 (P < 0.0001). Overall symptom severity scores decreased by a mean 50.42% from baseline to cycle 3 (2.58 ± 0.65 to 1.28 ± 0.83, P < 0.0001), corresponding to a change from distracting (moderate-severe) to barely noticeable. There were significant improvements in all measured individual physical and psychological symptoms from baseline to cycle 3 (all P < 0.0001). By cycle 3, 88% of participants agreed that the supplement reduced symptom severity, and 82% agreed that the supplement reduced symptom duration.
CONCLUSIONS: These findings suggest that this novel multinutrient supplement may be of interest as a nutritional approach to support females throughout the menstrual cycle, warranting further investigation in randomized, placebo-controlled trials.This trial was registered on clinicaltrials.gov as NCT07267728.