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

NCT07433049 | Recruiting DMC

• 1 other identifier: 2025-064
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose Control; Mental Health; Musculoskeletal Health; Body Composition

Keywords

Multivitamin and mineral supplementation; Women; Metabolic health; Mental health; Muscle health

Outcome Measures

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.

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

Secondary Outcomes (13)

• Anthropometric Measurements

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

• Blood Pressure Measurements

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

• Body Composition Assessment

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

• 36-Item Short Form Survey (SF-36)

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

• Menopausal Status

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

Study Arms (2)

Multivitamin/mineral (MVM) study product

EXPERIMENTAL

One MVM study product to be taken once a day for 52 weeks

Dietary Supplement: Multivitamin/mineral study product

Placebo study product

PLACEBO COMPARATOR

One placebo study product to be taken once a day for 52 weeks

Dietary Supplement: Multivitamin/mineral study product

Interventions

Multivitamin/mineral study product DIETARY_SUPPLEMENT

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

Multivitamin/mineral (MVM) study product; Placebo study product

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 40-60 years old
• Chinese, Malay or Indian
• BMI between 23.0-35.0 kg/m2
• Proficient in English language
• Willing to comply with study protocol \& provide informed consent

You may not qualify if:

• 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
• Participating in other nutritional intervention studies
• Taking oral corticosteroids, anti-psychotic and/or weight loss drugs
• Having planned hospitalization in the next 12 months
• Planning to have major diet changes in the next 12 months
• Taking a medically prescribed supplement(s) that contains 3 or more of the ingredients of the study product
• Taking a non-prescribed supplement(s) that contains 3 or more of the ingredients of the study product in the last 1 month

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• HALEON: collaborator

Study Sites (1)

Institute for Human Development and Potential (IHDP)

Singapore, 117597, Singapore

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Geritol

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Johan Eriksson, MD

CONTACT

80616604; johan_eriksson@a-star.edu.sg

Mya Thway Tint, PhD

CONTACT

mya_thway_tint@a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Principal Investigator

Model Details: A single center, prospective, double-blind, placebo-controlled Randomised Control Trial. Eligible women will be randomised at baseline to either intervention or control group. Participants will receive the assigned intervention from baseline to week 52.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 25, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)