Study of Grape Consumption in Adaptation to Seasonal Photoperiod

NCT07886788 | Active Not Recruiting

• 2 other identifiers: 1472026PID2023-150028OB-I00
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to learn whether consuming grapes during their natural season can help the body adapt to the shorter daylight hours of winter. The study includes men and women aged 30-70 years with either normal weight or overweight or obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). The main questions it aims to answer are:

• Does seasonal grape consumption change circulating microRNAs, small molecules involved in regulating gene activity?
• Does grape consumption influence sleep, physical activity, metabolic markers, body composition, muscle function, and gut bacteria during the transition to winter? Within each population group, researchers will compare participants consuming yogurt with freeze-dried grape powder with participants consuming the same yogurt without grape powder. Both groups will receive the same Mediterranean-style dietary guidance. Participants will:
• Consume two yogurts daily for 3 weeks, either with or without a total daily dose of 16 grams of freeze-dried grape powder, equivalent to approximately 80 grams of fresh grapes.
• Complete a further 2 weeks of follow-up without the grape intervention.
• Attend an initial information visit and three assessment visits for blood sampling, stool sample collection, and measurements of body composition and muscle function.
• Wear a wrist device to monitor sleep and physical activity.
• Complete questionnaires, dietary records, and a sleep diary.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Overweight; Obesity & Overweight

Keywords

Seasonal grape consumption; Grape polyphenols; Chrononutrition; Seasonal photoperiod; Circadian rhythms; Metabolic adaptation; Circulating microRNAs; Epigenetics; Gut microbiota; Sleep-wake patterns

Outcome Measures

Primary Outcomes (1)

• Change in circulating plasma microRNA expression

  Differential expression of circulating microRNAs in plasma, comparing changes from baseline between the grape supplementation and control arms at the end of the intervention and after follow-up.

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

Secondary Outcomes (37)

• Change in DNA methylation in promoter regions of selected genes

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

• Change in serum metabolomic profile

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

• Change in gut microbiota diversity and composition

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

• Change in body weight

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

• Change in body mass index

  Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5).

Study Arms (2)

Experimental: Freeze-Dried Grape Powder with Yogurt

EXPERIMENTAL

Participants consume 16 g of freeze-dried grape powder daily, equivalent to approximately 80 g of fresh grapes, divided between two servings of plain, low-fat yogurt without added sugar, taken in the morning and afternoon for 3 weeks. Participants also receive Mediterranean-style dietary guidance. The intervention is followed by 2 weeks without grape supplementation.

Dietary Supplement: Freeze-Dried Grape Powder; Other: Plain Low-Fat Yogurt; Behavioral: Mediterranean-Style Dietary Guidance

Control: Yogurt Alone

ACTIVE COMPARATOR

Participants consume two servings of plain, low-fat yogurt without added sugar daily, taken in the morning and afternoon for 3 weeks, without freeze-dried grape powder. Participants receive the same Mediterranean-style dietary guidance as the experimental arm. The intervention is followed by a 2-week follow-up period.

Other: Plain Low-Fat Yogurt; Behavioral: Mediterranean-Style Dietary Guidance

Interventions

Freeze-Dried Grape Powder DIETARY_SUPPLEMENT

Freeze-dried Cabernet Sauvignon grape powder administered orally at a total dose of 16 g/day, equivalent to approximately 80 g of fresh grapes. The daily dose is divided into two servings, mixed with plain, low-fat yogurt without added sugar and consumed in the morning and afternoon for 3 weeks during the local grape harvest season. This is followed by 2 weeks without grape supplementation.

Experimental: Freeze-Dried Grape Powder with Yogurt

Plain Low-Fat Yogurt OTHER

Two daily servings of plain, low-fat yogurt without added sugar, consumed in the morning and afternoon for 3 weeks.

Control: Yogurt Alone; Experimental: Freeze-Dried Grape Powder with Yogurt

Mediterranean-Style Dietary Guidance BEHAVIORAL

Both arms receive the same dietary guidance based on a Mediterranean dietary pattern.

Control: Yogurt Alone; Experimental: Freeze-Dried Grape Powder with Yogurt

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 30-70 years.
• Body mass index (BMI) between 18.5 and 39.9 kg/m².
• Written informed consent.
• Membership in one of the following population groups:
• Normal-weight group: BMI between 18.5 and 24.9 kg/m².
• Overweight or obesity group: BMI between 25.0 and 39.9 kg/m² and a diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD).

You may not qualify if:

• Alcohol consumption exceeding 10 g/day or use of other toxic substances.
• Acute or chronic liver disease of an etiology other than MASLD.
• Active inflammatory, infectious, or neoplastic disease.
• Pregnancy.
• Women receiving hormonal contraceptive treatment.
• Antibiotic treatment within the 4 weeks before enrollment.
• Chronic treatment with corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs).
• Milk protein allergy.
• Grape-related food intolerances.

Sponsors & Collaborators

• University Rovira i Virgili: lead

Study Sites (1)

Hospital Universitari Joan XXIII - Unitat d'Investigació Clínica, IRB CatSud

Tarragona, Tarragona, 43005, Spain

Location

Related Publications (13)

• Escobar-Martinez I, Arreaza-Gil V, Arola-Arnal A, Muguerza B, Mulero M, Suarez M, Torres-Fuentes C. Circannual Rhythms Affect the Bioavailability of Phenolic Compounds from Grape Seed Proanthocyanidins Extract Differently in Healthy and Obese Fischer 344 Rats. J Agric Food Chem. 2025 Oct 8;73(40):25329-25339. doi: 10.1021/acs.jafc.5c03952. Epub 2025 Sep 26.

  PMID: 41002217 BACKGROUND

• Ribas-Latre A, Baselga-Escudero L, Casanova E, Arola-Arnal A, Salvado MJ, Blade C, Arola L. Dietary proanthocyanidins modulate BMAL1 acetylation, Nampt expression and NAD levels in rat liver. Sci Rep. 2015 Jun 8;5:10954. doi: 10.1038/srep10954.

  PMID: 26051626 BACKGROUND

• Soliz-Rueda JR, Lopez-Fernandez-Sobrino R, Torres-Fuentes C, Bravo FI, Suarez M, Mulero M, Muguerza B. Metabolism disturbance by light/dark cycle switching depends on the rat health status: the role of grape seed flavanols. Food Funct. 2023 Jul 17;14(14):6443-6454. doi: 10.1039/d3fo00260h.

  PMID: 37377055 BACKGROUND

• Arreaza-Gil V, Palacios-Jordan H, Romero MDM, Torres-Fuentes C, Rodriguez MA, Remesar X, Fernandez-Lopez JA, Arola-Arnal A. Administration time effect of dietary proanthocyanidins on the metabolome of Fischer 344 rats is sex- and diet-dependent. Food Funct. 2023 Jul 31;14(15):6941-6956. doi: 10.1039/d3fo01551c.

  PMID: 37432474 BACKGROUND

• Ribas-Latre A, Baselga-Escudero L, Casanova E, Arola-Arnal A, Salvado MJ, Arola L, Blade C. Chronic consumption of dietary proanthocyanidins modulates peripheral clocks in healthy and obese rats. J Nutr Biochem. 2015 Feb;26(2):112-9. doi: 10.1016/j.jnutbio.2014.09.006. Epub 2014 Oct 13.

  PMID: 25459887 BACKGROUND

• Ribas-Latre A, Del Bas JM, Baselga-Escudero L, Casanova E, Arola-Arnal A, Salvado MJ, Arola L, Blade C. Dietary proanthocyanidins modulate melatonin levels in plasma and the expression pattern of clock genes in the hypothalamus of rats. Mol Nutr Food Res. 2015 May;59(5):865-78. doi: 10.1002/mnfr.201400571. Epub 2015 Mar 23.

  PMID: 25677201 BACKGROUND

• Rodriguez RM, Colom-Pellicer M, Hernandez-Baixauli J, Calvo E, Suarez M, Arola-Arnal A, Torres-Fuentes C, Aragones G, Mulero M. Grape Seed Proanthocyanidin Extract Attenuates Cafeteria-Diet-Induced Liver Metabolic Disturbances in Rats: Influence of Photoperiod. Int J Mol Sci. 2024 Jul 14;25(14):7713. doi: 10.3390/ijms25147713.

  PMID: 39062955 BACKGROUND

• Arreaza-Gil V, Escobar-Martinez I, Suarez M, Bravo FI, Muguerza B, Arola-Arnal A, Torres-Fuentes C. Gut Seasons: Photoperiod Effects on Fecal Microbiota in Healthy and Cafeteria-Induced Obese Fisher 344 Rats. Nutrients. 2022 Feb 8;14(3):722. doi: 10.3390/nu14030722.

  PMID: 35277081 BACKGROUND

• Arola-Arnal A, Cruz-Carrion A, Torres-Fuentes C, Avila-Roman J, Aragones G, Mulero M, Bravo FI, Muguerza B, Arola L, Suarez M. Chrononutrition and Polyphenols: Roles and Diseases. Nutrients. 2019 Oct 30;11(11):2602. doi: 10.3390/nu11112602.

  PMID: 31671606 BACKGROUND

• Ibars M, Aragones G, Ardid-Ruiz A, Gibert-Ramos A, Arola-Arnal A, Suarez M, Blade C. Seasonal consumption of polyphenol-rich fruits affects the hypothalamic leptin signaling system in a photoperiod-dependent mode. Sci Rep. 2018 Sep 11;8(1):13572. doi: 10.1038/s41598-018-31855-y.

  PMID: 30206280 BACKGROUND

• Iglesias-Carres L, Mas-Capdevila A, Bravo FI, Arola L, Muguerza B, Arola-Arnal A. Exposure of Fischer 344 rats to distinct photoperiods influences the bioavailability of red grape polyphenols. J Photochem Photobiol B. 2019 Oct;199:111623. doi: 10.1016/j.jphotobiol.2019.111623. Epub 2019 Sep 10.

  PMID: 31525717 BACKGROUND

• Manocchio F, Soliz-Rueda JR, Ribas-Latre A, Bravo FI, Arola-Arnal A, Suarez M, Muguerza B. Grape Seed Proanthocyanidins Modulate the Hepatic Molecular Clock via MicroRNAs. Mol Nutr Food Res. 2022 Dec;66(23):e2200443. doi: 10.1002/mnfr.202200443. Epub 2022 Oct 26.

  PMID: 36189890 BACKGROUND

• Soliz-Rueda JR, Lopez-Fernandez-Sobrino R, Bravo FI, Aragones G, Suarez M, Muguerza B. Grape Seed Proanthocyanidins Mitigate the Disturbances Caused by an Abrupt Photoperiod Change in Healthy and Obese Rats. Nutrients. 2022 Apr 27;14(9):1834. doi: 10.3390/nu14091834.

  PMID: 35565801 BACKGROUND

Related Links

• Publications from the Nutrigenomics Research Group at Universitat Rovira i Virgili.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Randomized, parallel-group nutritional intervention study with two population cohorts: adults with normal weight and adults with overweight or obesity and MASLD.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-09

Locations

ES (1)