AzTrials
AzTrials

ObesityPHYTOENIXNCT05178667

Food Supplement Effect on Overweight or Moderate Obesity

A study testing High dose, Low dose and Maltodextrin in people with Obesity, run by Institut Pasteur de Lille at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
High dose, Low dose and Maltodextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
2 sitesFrance
Study dates
6 Jan 2022to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI between 25 and 35 kg / m² (limits excluded),
  • Having a fat mass (measured by impedance balance in kg) according to the following table:
  • Men 18-29 years : ≥ 21.2 kg; Men 30-49 years : ≥ 21.6 kg; Men 50-65 years : ≥ 23.8 kg; Women 18-29 years : ≥ 31.4 kg; Women30-49 years : ≥ 31.8 kg; Women 50-65 years : ≥ 33.9 kg.
  • Willing to observe dietetic plan in accordance with dietitian evaluation,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme.

Who cannot join

  • Dyslipidemia or hyperlipidemia:
  • Fasting total cholesterol ≥ 3.0 g / L
  • Fasting triglycerides> 2.5 g / L
  • with heterozygous familial hypercholesterolemia,
  • Diabetes treated or not with medication,
  • With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,
Show all 33Show fewer
  • TSH abnormal or not stable for at least 3 months,
  • History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,
  • With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,
  • Taking drugs known to have an impact on weight management (corticosteroids, neuroleptics, anti-HIV triple therapy, etc.) in the month preceding inclusion and / or likely to consume them during the test,
  • Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
  • Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,
  • Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,
  • Non stable weight during the last 6 months (>5% change in total weight),
  • With metal implant (to allow DEXA measurement),
  • Blood donation in the month before the start of the study and during the study,
  • Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and / or likely to take during the test,
  • Following or having followed a hypocaloric diet (energy intake <1,500 kCal / day) in the month preceding inclusion and / or likely to undertake this diet during the test,
  • Following a particular diet (vegan),
  • Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
  • Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,
  • Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,
  • Bariatric surgery or who has a gastroplasty ring,
  • Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,
  • Consuming illicit drugs,
  • Using topical anti-cellulite treatments,
  • For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,
  • Known allergy to one of the component of the supplement (carrot and rose hip),
  • Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • NutrInvest - Institut Pasteur de Lille

    Lille, Nord, 59019

  • Institute of Cardiometabolism And Nutrition

    Paris, 75013

Other trials in France

About this study

Official title: Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.

The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.

Conditions
Obesity
Being tested
High dose, Low dose, Maltodextrin
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High doseDietary supplement

    Food supplements are consumed during 3 months by healthy volunteers.

  • Low doseDietary supplement

    Food supplements are consumed during 3 months by healthy volunteers.

  • MaltodextrinDietary supplement

    Food supplements are consumed during 3 months by healthy volunteers.

Study groups in NCT05178667
Study groupRoleWhat they receive
High doseExperimental4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
Receives: Dietary Supplement: High dose
Low doseActive comparator4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
Receives: Dietary Supplement: Low dose
MaltodextrinPlacebo comparator4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline weight at 3 months

    Weight (unit: kg)

    Measured: 0 month (inclusion), 3 months

Secondary outcomes (20)

  1. Body mass composition by DEXA (dual energy x-ray absorptiometry)

    Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)

    Measured: 0 month (inclusion), 3 months

  2. Anthropometric parameters

    Hip circumference, waist circumference and thigh circumference (unit: cm)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  3. Fasting glycemia

    Carbohydrate metabolism: Fasting glycemia (unit: g/l)

    Measured: 0 month (inclusion), 3 months

  4. Insulinemia

    Carbohydrate metabolism: Insulinemia (unit: mU/l)

    Measured: 0 month (inclusion), 3 months

  5. HbA1c

    Carbohydrate metabolism: HbA1c (unit: percent)

    Measured: 0 month (inclusion), 3 months

  6. HOMA index

    Carbohydrate metabolism: determination of the HOMA index (calculated)

    Measured: 0 month (inclusion), 3 months

  7. Lipid metabolism

    Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)

    Measured: 0 month (inclusion), 3 months

  8. Free fatty acids

    Lipid metabolism: free fatty acids (unit: micromol/l)

    Measured: 0 month (inclusion), 3 months

  9. Hepatic metabolism

    Creatinine (unit: mg/l)

    Measured: 0 month (inclusion), 3 months

  10. Transaminases

    Hepatic metabolism: ASAT/ALAT (unit: UI/l)

    Measured: 0 month (inclusion), 3 months

  11. Sedimentation rate

    Blood parameters: Sedimentation rate (unit: mm)

    Measured: 0 month (inclusion), 3 months

  12. Blood count

    Blood parameters: Blood count (unit: G/L)

    Measured: 0 month (inclusion), 3 months

  13. Thyroid Stimulating Hormone

    TSH (Thyroid Stimulating Hormone) (unit: mUI/l)

    Measured: 0 month (inclusion), 3 months

  14. High sensible C-reactive protein

    CRPhs (high sensible C-reactive protein) (unit: mg/l)

    Measured: 0 month (inclusion), 3 months

  15. Heart rate

    Hemodynamic parameters: Heart rate (unit: Pul/min)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  16. Blood pressure

    Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  17. Body mass composition by impedancemetry

    Lean body mass and total fat mass (unit: percent)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  18. Weight

    Anthropometric parameters: weight (unit: kg)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  19. Height

    Anthropometric parameters: height (unit: cm)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

  20. Body Mass Index

    Anthropometric parameters: determined Body Mass Index (unit: kg/m²)

    Measured: 0 month (inclusion), 1 month, 2 months, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start6 Jan 2022
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178667
Sponsor's protocol ID
2021-A02422-39
Acronym
PHYTOENIX
Status last verified
Dec 2022
First submitted
1 Dec 2021
Last updated
16 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing High dose, Low dose and Maltodextrin in people with Obesity, run by Institut Pasteur de Lille at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline weight at 3 months (time frame: 0 month (inclusion), 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in