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

InnoNext Sarl

Status and phase: Completed; Phase 3

Conditions: Micronutrient Deficiencies

Treatments: Other: Nutrition training and healthy lifestyle coaching; Dietary Supplement: Placebo Effervescent powder; Dietary Supplement: Active Effervescent Powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07031973

PACTR202402872415588

UHAS-REC L.7 16123-24 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apparently healthy students in their second and third years of study at University of Health and Allied Sciences, Fred N. Binka School of Public Health
• Females and males aged 18 - 25 years
• Agree to remain in the study area for the 26-week period of the follow-up
• Gives written informed consent

For female participants with childbearing potential:

• No plan to get pregnant the next 7 months (Acceptance of the requirement to use a highly effective form of birth control (herein referred to as condom) effective from consenting until at least week 24 after the final intake of Investigational Product (Month 6 visit).

Exclusion criteria

• Individuals taking routine micronutrient supplements
• History of food allergies
• Sensitivity to micronutrient supplement consumption and to any compositions of the micronutrients
• For females of child-bearing potential: pregnant as per serum pregnancy testing, or planning to become pregnant.
• Taking medications that could interact with the micronutrient supplements. Key medications which deplete the absorption of micronutrients include acid-suppressing and antacids, antiepileptic drugs (anti-convulsants), antibiotics, hormone replacement therapy (estrogens), digoxin, anti-inflammatory/analgesics
• Interested persons with severe anaemia (hemoglobin less than 7g/dl), as identified in the screening phase, will not be enrolled in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Training and Active Ingredient Arm (Arm 1)

Active Comparator group

Description:

Particiants receive a daily Investigational Product for 24 weeks plus Nutrition Training and Healthy Lifestyle Coaching

Treatment:

Dietary Supplement: Active Effervescent Powder

Other: Nutrition training and healthy lifestyle coaching

Active Ingredient Arm (Arm 2)

Active Comparator group

Description:

Participants receive a daily active Investigational Product for 24 weeks

Treatment:

Dietary Supplement: Active Effervescent Powder

Placebo Arm (Arm 3)

Placebo Comparator group

Description:

Participants receive a daily placebo Investigational Product for 24 weeks

Treatment:

Dietary Supplement: Placebo Effervescent powder