NCT07031973

The Effect of Micronutrient Supplementation on Nutrition Status and Well-being

The Effect of Micronutrient Supplementation in Combination With Healthy Lifestyle Coaching on Nutrition Status and Well-being: A 6-Month Intervention Study in Ghana

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: InnoNext Sarl · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Inadequate micronutrient status poses a significant challenge in Sub-Saharan African countries, including Ghana, and affects various demographics. The aim of the intervention study is to assess nutritional status and well-being through micronutrient supplementation with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana. The outcomes the study is assessing are: PRIMARY OUTCOME: The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching. Vitamin D status will be assessed as serum 25(OH) D in serum. SECONDARY OUTCOMES: The secondary objectives are to: 1. determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb. 2. Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well- being through targeted questionnaires. TRIAL DESIGN: This study is a 3-arm blinded randomized placebo-controlled trial among 151 young adults participants in Arm 1 receive a daily Investigational Product and attend nutrition training and healthy lifestyle coaching; participants in Arm 2 will receive an active Investigational Product; participants in Arm 3 will receive a placebo Investigational Product. Main data collection, including blood sampling for nutritional status will take place at Baseline (Day 0), Midpoint (Month 3) and Endpoint (Month 6). In addition, all participants will fill in a digital diary.

Detailed description

This study is a 6-month intervention study to assess the effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being will improve nutritional status with or without the combination of nutrition training and healthy lifestyle coaching among young adults in Ghana. The test product is an Effervescent powder that is Orange flavored containing multiple vitamins and minerals, in a single serving, packaged within a multi-layer structure foil sachet. Participants will be required to mix Effervescent powder with water before consumption. The placebo is also an Effervescent powder that is Orange flavored, but without active components, packaged within a multi-layer structure foil sachet. The placebo will be packaged in a manner that it looks and feels just like the micronutrient supplement with the only difference being the absence of the active ingredient in the micronutrient supplement. The primary outcome of this study is to determine if micronutrient supplement improves the vitamin D status of the study participants with or without additional Nutrition Training and Healthy Lifestyle Coaching (herein referred to as NuTHLiC), Vitamin D status will be assessed as serum 25(OH) D in serum. The secondary objectives are to: 1. determine if the provision of micronutrient supplement with or without additional NuTHLiC improves participants serum levels of vitamin B12, serum zinc, serum magnesium, serum ferritin and red blood cell Hb. 2. Assess the effect of micronutrient supplement with or without additional NuTHLiC on participants lifestyle habits and overall well-being through targeted questionnaires After consenting, blood samples will be taken for biochemical analyses and the participants will also be assessed through standardized questionnaires in addition to vitals and anthropometric measurements. The primary analysis will be intention-to-treat analysis. We fit a linear mixed effect model involving a random effect of participants within treatment groups and fixed effects of time and their interactions. The treatment effects will be shown as the mean difference (95% CI) in the change in serum 25(OH)D concentration between intervention and control groups. Model assumptions will be checked by inspecting the residual and quantile-quantile plot. Difference-in-difference (DID) will be used to determine the effect of each micronutrient supplement between the treatment (intervention) groups and the control (placebo) group. Sub-group analysis will also be used to contrast the factorial analysis.

Conditions

• Micronutrient Deficiencies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Effervescent Powder	Participants receive a daily sachet of effervescent powder that is Orange flavored, containing multiple vitamins and minerals
DIETARY_SUPPLEMENT	Placebo Effervescent powder	Participants receive a daily sachet of effervescent powder that is Orange flavored containing no active ingredients
OTHER	Nutrition training and healthy lifestyle coaching	Participants receive Nutrition training and healthy lifestyle coaching

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2025-06-22
• Last updated: 2025-11-14

Locations

1 site across 1 country: Ghana