NCT06681597

Brief Summary

To investigate the molecular mechanism of raspberry ketone on regulating obesity, the investigators studied the effect of raspberry ketone intake on FGF21 in plasma. The age of the volunteers were 18-60 years old, both male and female, without diabetes, hypertension and other diseases. After ingestion of raspberry ketone (500mg), 2ml of blood was collected at 0 hours, 3 hours and 6 hours , and the FGF21 content in plasma was measured using a commercial reagent kit. In addition, the investigators also studied the effect of raspberry ketone intake on energy metabolism 0 hours, 0.5 hours, 3 hours and 6 hours after consuming raspberry ketone (500mg).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for early_phase_1 obesity

Timeline
Completed

Started Jan 2024

Shorter than P25 for early_phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 2, 2024

Last Update Submit

November 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Impact of raspberry ketone consumption on plasma FGF21 level

    Through study completion, an average of 1 year

  • Impact of raspberry ketone consumption on energy expenditure

    The oxygen consumption, heart rate, carbon dioxide production were measured

    Through study completion, an average of 1 year

Study Arms (2)

Human administrated with raspberry ketone

EXPERIMENTAL
Dietary Supplement: Raspberry ketone

Human administrated with placebo

EXPERIMENTAL
Dietary Supplement: Raspberry ketone

Interventions

Raspberry ketoneDIETARY_SUPPLEMENT

Human consumed 500mg of raspberry ketone

Human administrated with placeboHuman administrated with raspberry ketone

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No drugs were taken before the human study

You may not qualify if:

  • Patients with hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanchang University

Nanchang, Jiangxi, 330047, China

Location

Related Publications (1)

  • Lopez HL, Ziegenfuss TN, Hofheins JE, Habowski SM, Arent SM, Weir JP, Ferrando AA. Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women. J Int Soc Sports Nutr. 2013 Apr 19;10(1):22. doi: 10.1186/1550-2783-10-22.

    PMID: 23601452BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes MellitusNon-alcoholic Fatty Liver Disease

Interventions

raspberry ketone

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 8, 2024

Study Start

January 10, 2024

Primary Completion

May 15, 2024

Study Completion

June 1, 2024

Last Updated

November 8, 2024

Record last verified: 2023-11

Locations