An Exploratory Investigation of Dietary Supplementation and Its Effect

HUM Nutrition

Status: Completed

Conditions: Quality of Life

Treatments: Dietary Supplement: Placebo; Dietary Supplement: HUM supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05037877

20220HUM

Details and patient eligibility

About

The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.

Full description

This will be a 2-arm randomized, double-blinded, placebo-controlled study.

Enrollment: 110 patients

Sex: Female

Ages: 38 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study
• Must be in good health (don't report any medical conditions asked in the screening questionnaire)
• Willing and able to provide written informed consent

Exclusion criteria

• Allergies to any test product ingredients
• Any other severe chronic disease
• Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
• Participating in an investigational health product research study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

HUM supplement - 1 capsule per day

Treatment:

Dietary Supplement: HUM supplement

Placebo group

Placebo Comparator group

Description:

Placebo supplement - 1 capsule per day

Treatment:

Dietary Supplement: Placebo