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Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults

NCT05333315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-07-19

No results posted yet for this study

Summary

In recent years, dietary supplement are of great interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical and anthropometric parameters.

Conditions

Interventions

DIETARY_SUPPLEMENT

IP1

IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks. OTHER: Placebo

DIETARY_SUPPLEMENT

IP2

IP2: One bag per day mixed in 200 mL of cold water or tea and consumed immediately, on an empty stomach, half an hour before breakfast for eight weeks. OTHER: Placebo

DIETARY_SUPPLEMENT

IP3

IP3: One bag per day in the morning, dissolved in a glass of warm water and three capsules per day with a glass of water or tea (one capsule at breakfast, one at lunch and one at dinner) for eight weeks. OTHER:Placebo

DIETARY_SUPPLEMENT

IP4

IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks. OTHER:Placebo

DIETARY_SUPPLEMENT

IP5

IP5: Formula 1: One capsule per day at breakfast with a glass of water for eight weeks and Formula 2: Two capsules a day at breakfast and at dinner with a glass of water for eight weeks. OTHER:Placebo

Sponsors & Collaborators

  • Biostile d.o.o.

    collaborator UNKNOWN

  • University of Primorska

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-07-01
Completion
2022-07-15

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333315 on ClinicalTrials.gov