Trial document




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  DRKS00005131

Trial Description

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Title

Dietary intervention trial: single blinded placebo-controlled, randomized study to assess anti-diabetic effects of daily bitter gourd consumption among pre-diabetics in Moshi, Tanzania

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Trial Acronym

MOCHI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study examines anti-diabetic effects of a daily bitter gourd consumption of 2.5 g among pre-diabetic people. Pre-diabetes is definded according to the American Diabetes Association. A person with a fasting plasma glucose level between 100 and below 126 mg/dl (5.6 – 6.9 mmol/l) is considered as pre-diabetic.
Over a period of two months one group will receive bitter gourd sachets and one group placebo sachets. Then, a four week wash-out period, where no sachets are taken, is conducted. After that the group which received bitter gourd sachets will now get the placebo sachets and vice versa. Before and after each intervention phase with the sachets, different parameters in regard to blood sugar and blood lipids as well as body weight will be assessed. The study is going to take place in Moshi, Tanzania.

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Brief Summary in Scientific Language

The planned dietary intervention study aims at assessing anti-diabetic effects of daily bitter gourd drink consumption of 2.5 g powder over the course of eight weeks among pre-diabetic persons. It is a single blinde, placebo-controlled, randomized, cross-over designed dietary intervention study. During the trial, data will be collected in regards to fasting plasma glucose levels, HbA1c, fructosamine, insulin, and lipids, anthropometrics, and blood pressure as well as socio-economic and medical history information, dietary intake, and physical activity,. The study will be conducted at the Kilimanjaro Clinical Research Centre, Moshi Tanzania.

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Organizational Data

  •   DRKS00005131
  •   2013/07/24
  •   [---]*
  •   no
  •   Approved
  •   [---]*, National Institute for Medical Research (NIMR), NIMR/HQ/r.8a/Vol.IX/1551
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Secondary IDs

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Health Condition or Problem studied

  •   Pre-diabetes
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Interventions/Observational Groups

  •   Bitter gourd sachets:
    Bitter gourd powder (g): 2.5
    Cucumber powder (g): 0.75
    Alpha-cyclodextrin* (g): 0.75
    Beta-cyclodextrin (mg): 75
    Steviol glycoside (mg): 15
    Total (g) 4.090
    *containing 2% (v/w) of lemon peel oil
    Participants are requested to consume one sachet per day after the main meal, dissolved in 150 ml water. Sachets are going to be consumed over the course of eight weeks, followed by a four week wash-out period.
  •   Placebo sachet:
    Cucumber powder (g): 3.25
    Alpha-cyclodextrin* (g) : 0.75
    Beta-cyclodextrin (mg): 75
    Steviol glycoside (mg): 15
    Total (g): 4.090
    *containing 2% (v/w) of lemon peel oil
    Participants are requested to consume one sachet per day after the main meal, dissolved in 150 ml water. Sachets are going to be consumed over the course of eight weeks, followed by a four week wash-out period.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   patient/subject
  •   Placebo
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Fasting plasma glucose: measured each at baseline and after each intervention of eight weeks (end assessment) as well as during the weekly check-ups.

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Secondary Outcome

HbA1c, insulin, triglycerides, high-density lipoprotein, cholesterol:measured each at baseline and after each intervention of eight weeks (end assessment)
Body weight, waist circumference, blood pressure: measured each at baseline and after each intervention of eight weeks (end assessment) as well as during the weekly check-ups.

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Countries of Recruitment

  •   Tanzania, United Republic of
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2013/07/28
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   60   Years
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Additional Inclusion Criteria

- BMI > 27 - < 35 kg/m²
- WC > 80 cm (women) > 94 cm (men)
- Being pre-diabetic according to:
- Fasting plasmae glucose (FPG) ≥ 100 – 125 mg/dl (≥ 5.6 – 6.9 mmol/l) on two screening days or FPG ≥ 100 – 125 mg/dl and HbA1c ≥ 5.7% < 6.5% on one screening day

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Exclusion Criteria

- Having diagnosed disease
- Having G6PD deficiency
- Taking any kind of medication regularly
- High blood pressure (>140/>90)
- Low blood pressure (<90/<60)
- Being mentally ill
- Pregnancy or planned pregnancy
- Breast-feeding
- Heavy alcohol consumption

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Addresses

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    • Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung (BMZ)
    • Stresemannstraße 94
    • 10963  Berlin
    • Germany
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    • AVRDC - The World Vegetable Center; KCMC - Kilimanjaro Christian Medical Centre
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Justus-Liebig Universität Gießen, Institut für Ernährungswissenschaft - Ernährung in Entwicklungsländern
    • Ms.  Christine  Ludwig 
    • Wilhelmstr. 20
    • 35392  Giessen
    • Germany
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    • Justus-Liebig Universität Gießen, Institut für Ernährungswissenschaft - Ernährung in Entwicklungsländern
    • Ms.  Christine  Ludwig 
    • Wilhelmstr. 20
    • 35392  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung
    • Stresemannstraße 94
    • 10963  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.