Inclusion Criteria:
Female Age 40-65 years (inclusive). Body Mass Index (BMI) between 25.0 and 32.5 kg/m².
Menopausal Status: participants need to be in the menopausal transition or post-menopause; these are defined as:
1. Menopausal transition: defined by persistent menstrual cycle length variability, without a history of ≥12 consecutive months of amenorrhea (i.e., post-menopause not yet reached). Any menstrual bleeding must be spontaneous and not induced by exogenous hormones.
2. Post-menopause: defined as amenorrhea ≥12 consecutive months not attributable to pregnancy, lactation, exogenous hormones, surgery, or other medical causes.
Literate in English. Able to understand study instructions and required assessments. Treatment Stability
1. Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period.
2. Initiation, discontinuation, or dose change within the past 8 weeks of any of the following will be exclusionary:
i. Psychotropic medications known to materially affect fatigue, sleep, or mood, including antidepressants, anxiolytics, sedative-hypnotics, mood stabilizers, or antipsychotic medications.
ii. Therapies specifically intended to treat menopausal symptoms (other than those explicitly permitted), including non-systemic hormonal agents, compounded hormone preparations, or pharmacologic agents prescribed for menopausal symptom relief.
iii. Supplement-based interventions initiated or modified for the purpose of improving sleep, or energy (e.g., adaptogens, sleep aids, energy-enhancing formulations).
c. Participants must agree to maintain stable use of all permitted medications and supplements and not initiate new treatments likely to affect sleep, mood, or energy during the study period.
Informed Consent and Study Readiness
1. Able and willing to provide written informed consent prior to participation.
2. Willing to comply with all study procedures and protocol requirements.
3. Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
Exclusion Criteria:
Reproductive Stage Cannot Be Reliably Classified:
1. Use, within the preceding 3 months of systemic hormonal therapies that alter menstrual bleeding patterns, including systemic hormonal contraception, hormone replacement therapy (HRT), or GnRH analogs.
2. History of hysterectomy, as menstrual bleeding-based staging cannot be applied.
3. Pregnancy, \<6 months postpartum, or lactational amenorrhea, or known medical causes of amenorrhea.
4. History of bilateral oophorectomy (surgical menopause)
Allergy/Hypersensitivity:
a. Participants with known fish allergy
Major Psychiatric Conditions likely to be significant factor in weight gain:
a. Recent antidepressant or anti-psychotic initiation or dose change. Current or recent use (last 3-6 months) of systemic hormone replacement therapy (HRT), selective estrogen receptor modulators (SERMs), or other pharmacologic therapies intended to treat menopausal symptoms.
Local low-dose vaginal estrogen preparations used for urogenital symptoms (e.g., creams, tablets, or rings) are permitted.
High-dose iron supplements or IV iron. Sleep medications Strong herbal or phytoestrogen supplements (soy, red clover, etc.). Use of protein hydrolysate supplements. Vegan or vegetarian
Current participation in:
1. Structured weight-loss programs.
2. New vigorous exercise programs (initiated in last 3 months). Medical Conditions Affecting Menstrual Function
a. Clinically diagnosed endocrine disorders known to affect menstruation (e.g., uncontrolled thyroid disease, hyperprolactinemia, polycystic ovary syndrome, unless stable and investigator-approved).
History of cancer (except localized skin cancer without metastases) within 1 year prior to screening.
Significant Comorbid Medical Conditions
1. History or presence of clinically significant or uncontrolled cardiovascular, renal, or hepatic disease.
2. Active systemic infection (e.g., Lyme disease, tuberculosis, HIV).
3. Sleep apnea that is untreated or inadequately controlled.
4. Uncontrolled hypothyroidism or hyperthyroidism.
5. Active systemic inflammatory or autoimmune disease likely to materially contribute to weight gain through impaired mobility or via treatment with corticosteroid therapy.
6. Clinically significant anemia or iron deficiency requiring active treatment Impaired Gastrointestinal Absorption
History or presence of gastrointestinal disease, surgery, or functional disorder known to impair digestion or absorption of orally administered compounds, including:
i. Celiac disease ii. Short bowel syndrome or malabsorption syndromes iii. Chronic pancreatitis or exocrine pancreatic insufficiency iv. Prior bariatric or gastric surgery b. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) requiring ongoing systemic therapy (including steroid, immunomodulatory, or monoclonal antibody therapy).
Surgery: major surgery within 3 months prior to screening or planned during the study period.
Substance Use History History of clinically significant alcohol or substance use disorder within the past three years, or alcohol intake significantly above accepted public health thresholds.
