Impact of Supplementation in Improving Metabolic Health Outcomes (ISMOS) Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorInstitute for Human Development and Potential (IHDP), Singapore

About this trial

This study investigates the role of multivitamin and multimineral (MVM) supplementation in improving metabolic, musculoskeletal, and mental health among midlife Asian women aged 40-60 years, a critical period marked by hormonal and physiological transitions from pre- to post-menopause. Evidence from the GUSTO cohort in Singapore has shown that higher plasma levels of vitamins B6, B9, B12, and D are associated with better metabolic profiles, insulin sensitivity, and mental wellbeing, while deficiencies are linked to increased metabolic and psychological risks. Given that vitamin insufficiency and central obesity are highly prevalent among Asian women even at lower BMI, this randomized, double-blind, placebo-controlled trial will evaluate whether 12 months of daily MVM supplementation can reduce MetaboAge and improve metabolic, mental, and muscle health outcomes compared with placebo. Findings will inform preventive strategies for extending health span and mitigating chronic disease risks among midlife women in Asia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 40-60 years old

Chinese, Malay or Indian

BMI between 23.0-35.0 kg/m2

Proficient in English language

Disqualifiers

Pregnant or planning a pregnancy

Diagnosis with Diabetes, Polycystic Ovary Syndrome (PCOS), autoimmune diseases, chronic organ failure, severe heart disease, eating disorders and/or other medical conditions which in the PI's judgment which may affect study outcomes

Fasting glucose value ≥ 7.0 mmol/L

Active cancer or treatment of cancer in the last 3 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multivitamin/mineral study product

    Dietary supplement

    Participants will be randomised into one of the two study treatment arms

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Multivitamin/mineral (MVM) study productExperimental treatment 1 intervention
Group B: Placebo study productPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in MetaboAge

MetaboAge is a composite biomarker of metabolic aging derived from proton nuclear magnetic resonance (\^1H-NMR) metabolomics profiling of serum samples. It reflects overall metabolic health and correlates with cardiometabolic risk and insulin sensitivity. The expected outcome is that daily multivitamin/multimineral (MVM) supplementation for 12 months will result in a reduction in MetaboAge compared with placebo, indicating improved metabolic profile and slower metabolic aging. The change in MetaboAge will be calculated as the difference between post-intervention and baseline values. A negative change in MetaboAge represents metabolic rejuvenation or improvement in metabolic health status.

Time frame
Changes in MetaboAge over one year, including: Week 0 (Baseline), Week 26 (Midpoint) and Week 52 (Endpoint)

Secondary outcomes

1

Anthropometric Measurements

Participants will be measured for their height in m and weight in kg. Height and weight will be combined to report BMI in kg/m\^2.

Time frame
Week 0 (Baseline), Week 26 (Midpoint), Week 52 (Endpoint)
2

Blood Pressure Measurements

Blood pressure will be measured using an automated blood pressure monitor.

Time frame
Week 0 (Baseline), Week 26 (Midpoint), Week 52 (Endpoint)
3

Body Composition Assessment

Body composition will be assessed using multi-frequency bioelectrical impedance analysis (BIA) with the InBody 970 (InBody Co., Seoul, Korea). Participants will be measured in a standing position using an 8-point tactile electrode system (hands and feet), and impedance will be recorded across multiple frequencies to estimate total and segmental lean mass, fat mass, and body fat percentage.

Time frame
Week 0 (Baseline), Week 26 (Midpoint), Week 52 (Endpoint)
4

36-Item Short Form Survey (SF-36)

Health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36), a validated instrument measuring eight domains of physical and mental wellbeing: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain score and the overall physical and mental component summary scores will be calculated according to standardized scoring procedures. The expected outcome is that 12 months of daily multivitamin/multimineral (MVM) supplementation will lead to improvement in SF-36 scores compared with placebo, reflecting better perceived physical and mental wellbeing during the midlife transition. The change from baseline (ΔSF-36) will be computed for total and domain-specific scores, with higher positive values indicating improved quality of life.

Time frame
Week 0 (Baseline), Week 26 (Midpoint), Week 52 (Endpoint)

Other outcomes

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