- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04953936
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
13. september 2021 opdateret af: Yuxiang Liang, West China Hospital
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
The purpose of this study is to assess the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in Chinese adults with obesity during the weight loss process using calorie restriction.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yuxaing Liang
- Telefonnummer: 0086-13982250862
- E-mail: yx45liang@sina.com
Studiesteder
-
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Sichuan
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Chengdu, Sichuan, Kina, 610064
- West China Hospital,Sichuan University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women aged 30-50 years
- Currently having obesity defined by body mass index (BMI) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales)
- Having an intention to lost weight via caloric restriction
- Apparently healthy and able to walk independently
- Able to eat independently to meet their energy needs
- Without significant body weight change in the last 6 month (less than 5% change in body weight)
- Having sedentary habit defined by Sedentary Behavior Research Network
- Able to collaborate with the research staff.
Exclusion Criteria:
- Having a history of intolerance to enteral nutrition, food (e.g., lactose intolerance), or being allergic to the components of our HMB-enriched nutritional supplements (e.g., soy or corn);
- Having any implants (e.g., pacemakers);
- Current use of other nutritional supplements or drugs that may have an impact on the effectiveness of the intervention (e.g., glucocorticoids, antineoplastic drugs, antituberculosis drugs, sedatives, antipsychotics, muscle relaxants, monoamine oxidase inhibitors, antibiotics) within 3 months prior to enrollment;
- Secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants);
- Clinically visible edema;
- Trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment;
- Pregnancy, having pregnancy plans, or lactation;
- Individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.);
- Swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism);
- Having a history of diabetes, respiratory diseases, cardiovascular diseases, uncontrolled hypertension, kidney diseases, digestive system diseases, renal insufficiency, mental illness, neurological diseases, hematologic diseases, liver diseases (except for fatty liver), chronic infection (e.g., tuberculosis), immune system diseases, joint disorders, any type of tumor;
- Alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day);
- Difficulty to comply with the study protocol;
- Other conditions that indicate the individuals are inappropriate for participation in this study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: HMB
The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
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The participants will receive oral HMB-enriched nutritional supplements (65 g, once daily), which include soybean isolate protein, flaxseed oil powder, yam powder, whey protein, oligomeric isomaltose powder, cocoa powder, medium-chain fatty acid powder, calcium beta-hydroxy-beta-methylbutyrate, sunflower seed oil powder, L-glutamine, wheat germ powder, membrane isolated casein, wheat oligopeptide, konjac flour, vitamin E, vitamin D, stevioside, edible flavors.
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
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Placebo komparator: Placebo
The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
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Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
Placebo (maltodextrin 65 g once daily) with the same package as the intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The mean change in whole-body skeletal muscle mass (SMM)
Tidsramme: 12 weeks
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The whole-body skeletal muscle mass (SMM)
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The mean change in appendicular skeletal muscle mass (ASMM)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in trunk skeletal muscle mass (TSMM)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in total body fat mass (BFM)
Tidsramme: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in total appendicular body fat mass (ABFM)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in trunk body fat mass (TBFM)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in basal metabolic rate (BMR)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in phase angle (PA)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in body weight (BW)
Tidsramme: 12 weeks
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
|
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The mean change in handgrip strength (HGS)
Tidsramme: 6 and 12 weeks
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A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .
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6 and 12 weeks
|
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The mean change in waist circumference
Tidsramme: 6 and 12 weeks
|
A trained nurse will measure waist circumference using a tape at the level midway between the lower rib margin and the iliac crest with the participant breathing out gently.
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6 and 12 weeks
|
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The mean change in hip circumference
Tidsramme: 6 and 12 weeks
|
Hip circumference was measured as the maximum circumference over the buttocks
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6 and 12 weeks
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The mean change in physical activity
Tidsramme: From the beginning to weeks 3, 6, 9, and 12.
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It will be measured using self-reported International Physical Activity Questionnaire Short Form (IPAQ-SF).The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available.
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health related physical activity.
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From the beginning to weeks 3, 6, 9, and 12.
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The mean change in the score of the sit-to-stand test
Tidsramme: 6 and 12 weeks
|
A trained nurse will perform the 30-second sit-to-stand test ,which is a classic test for measuring the performance of lower extremity muscles.
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6 and 12 weeks
|
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The mean change in energy intake
Tidsramme: From the beginning to weeks 3, 6, 9, and 12
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It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
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From the beginning to weeks 3, 6, 9, and 12
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The mean change in lipid profiles
Tidsramme: 12 weeks
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It will be tested using standard method.
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12 weeks
|
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The mean change in fasting glucose
Tidsramme: 12 weeks
|
It will be tested using standard method.
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12 weeks
|
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The mean change in fasting insulin
Tidsramme: 12 weeks
|
It will be tested using standard method.
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12 weeks
|
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The mean change in HOMA-IR
Tidsramme: 12 weeks
|
It will be tested using standard method.
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12 weeks
|
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The mean change in albumin
Tidsramme: 12 weeks
|
It will be tested using standard method.
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jiaojiao Jiang, West China Hospital
- Studiestol: Ming Yang, West China Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
20. september 2021
Primær færdiggørelse (Forventet)
31. oktober 2021
Studieafslutning (Forventet)
31. december 2021
Datoer for studieregistrering
Først indsendt
12. juni 2021
Først indsendt, der opfyldte QC-kriterier
28. juni 2021
Først opslået (Faktiske)
8. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021(202)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med HMB-enriched Nutritional Supplements
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US Department of Veterans AffairsTrukket tilbage
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Chinese University of Hong KongAbbottRekrutteringSarkopeni | Muskuloskeletale abnormiteter | Bindevævssygdomme i alderdommenHong Kong