NCT05133778

The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults

The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults.

Detailed description

Background of the study: Polyphenols have been studied for their protective effect against the development of ROS-related diseases like cancers, cardiovascular diseases, diabetes, osteoporosis, and neurodegenerative diseases. The combined supplementation of pomegranate and sweet orange polyphenols could be an effective strategy to improve exercise performance, due to their antioxidant character and ability to stimulate NO production, to stimulate mitochondrial biogenesis and to accelerate muscle repair and decrease muscle tissue damage. The study aims to assess the effect of a combined supplementation of pomegranate and sweet orange extract on exercise capacity, physical activity, muscle strength and quality of life in healthy adults. Objective of the study: The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults (40 - 65 y). Study design: Randomized, double-blind, placebo-controlled parallel trial Study population: Healthy, overweight, sedentary adults between 40 and 65 years old. Intervention: 12-week supplementation with 650 mg sweet orange and pomegranate extract (2 capsules per day) compared to placebo (760 mg maltodextrin). Primary outcome of the study: Change in aerobic capacity (VO2max), assessed with an Ekblom-Bak submaximal cycling test. Secondary study parameters/outcome of the study: * Daily physical activity as determined by accelerometer * Dietary intake as measured by a 3-day food record * Handgrip strength * Muscle cell proliferation and differentiation and mitochondrial biogenesis assessed in skeletal muscle biopsies * Quality of Life as measured by the WHO-QOL-100 questionnaire * General health as measured by SF-36 questionnaire * Vitality as measured by the Dutch Vitality Questionnaire (Vita-16) * Cardiometabolic health biomarkers, cortisol, C-reactive protein determined with ELISA * Antioxidative capacity measured with a Trolox equivalent antioxidant capacity (TEAC) assay

Conditions

• Exercise Capacity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sweet orange and pomegranate extract	From the daily 650mg total supplementation of the investigational product, 250 mg will be of pomegranate extract containing 100mg of punicalagin. The remaining 400 mg will consist of sweet orange peel extract containing 360 mg of hesperidin.
OTHER	Maltodextrin control	Supplementation with 760 mg maltodextrin

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2021-11-24
• Last updated: 2025-06-13

Locations

1 site across 1 country: Netherlands